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  • Dispositivo 26490
  • Fabricante 33665
  • Evento 35826
  • Implante 7175
Device Recall Segmental fluted stem, 19x190mm str, Sterile,
  • Modelo / Serial
    Item Number: 00585205219, Lot Number Expiry Date Before: March 2027
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Belgium, Brazil, Bridgend Wales, Canada, Chile, Colombia, Dominican Republic, England, Eschbach, France, India, Italy, Japan, Jordan, Korea, Malaysia, Mexico, Netherlands, Nicaragua, Panama, Peru, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Taiwan, Thailand
  • Descripción del producto
    Segmental fluted stem, 19x190mm str, Sterile, || Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
  • Manufacturer
    Zimmer Biomet, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Segmental fluted stem, 19x190mm str, Sterile,
Device Recall Por fullct fem st 17x200mm, Sterile,
  • Modelo / Serial
    Item Number: 00784301708, Lot Number Expiry Date Before: July 2026
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Belgium, Brazil, Bridgend Wales, Canada, Chile, Colombia, Dominican Republic, England, Eschbach, France, India, Italy, Japan, Jordan, Korea, Malaysia, Mexico, Netherlands, Nicaragua, Panama, Peru, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Taiwan, Thailand
  • Descripción del producto
    Por fullct fem st 17x200mm, Sterile,
  • Manufacturer
    Zimmer Biomet, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Por fullct fem st 17x200mm, Sterile,
Device Recall Platinium CRT DF1 1711
  • Modelo / Serial
    All Serial Numbers
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implantable cardioverter defibrillator, || Biventricular or ventricular antitachycardia pacing, || Dual or single chamber arrhythmia detection || Product Usage: || PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT).
  • Manufacturer
    Sorin Group Italia SRL - CRF
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Platinium CRT DF1 1711
Device Recall VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESIS
  • Modelo / Serial
    Item Number: 00-7843-013-18 Lot Number: 62158840
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
  • Descripción del producto
    VERSYS 7.5 INCH BEADED FC REV 13.5X190MM STRAIGHT || Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
  • Manufacturer
    Zimmer Biomet, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESIS
Device Recall Sigma Pacemaker
  • Modelo / Serial
    Not all serial numbers within these ranges are affected. The specific serial numbers of affected devices may be found online at http://SigmaSNList.medtronic.com.  Model SS103: serial no. PJG160592H - PJG161247H, PJG162149H - PJG162607H, PJG163245H - PJG163805H, PJG165759H - PJG168541H, PJG170637H - PJG170921H, PJG428851H - PJG431485H, PJG677154S - PJG748119S, PJG748671S - PJG748710S, PJG748732S - PJG750863S, PJG751336S - PJG751944S, PJG752070S - PJG754744S, PJG231054M - PJG233721M, PJG748407C - PJG748670C, PJG748711C - PJG748722C. Model SS106: serial no. PJH117098H - PJH118839H, PJH624138S - PJH624610S, PJH626910S - PJH626967S. Model SS203: serial no. PJG165866H, PJG170641H - PJG170782H, PJG428850H - PJG431464H, PJG676637S - PJG681858S, PJG682490S, PJG683196S, PJG684296S - PJG689861S, PJG695412S, PJG747908S - PJG754745S, PJG231551M - PJG234346M. Model SS303: serial no. PJG162131H - PJG16371H, PJG427797H - PJG431510H, PJG676969S - PJG691865, PJG740396S - PJG757886S.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America
  • Descripción del producto
    Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker, models SS103, SS106, SS203, SS303
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Managment
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Sigma Pacemaker
FLEXSTENT Femoropopliteal SelfExpanding Stent System (Clinical Study Protocol FSS0003 (OPEN trial)
  • Modelo / Serial
    28 Catalog Numbers   CAC-50030-V2, CAC-60030-V2, CAC-70030-V2, CAC-80030-V2, CAC-50040-V2, CAC-60040-V2, CAC-70040-V2, CAC-80040-V2, CAC-50060-V2, CAC-60060-V2, CAC-70060-V2, CAC-80060-V2, CAC-50080-V2, CAC-60080-V2, CAC-70080-V2, CAC-80080-V2, CAC-50100-V2, CAC-60100-V2, CAC-70100-V2, CAC-80100-V2, CAC-50120-V2, CAC-60120-V2, CAC-70120-V2, CAC-80120-V2, CAC-50150-V2, CAC-60150-V2, CAC-70150-V2, CAC-80150-V2
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and the states of: AZ, CA, CT, FL, GA, IA, IL, LA, MD, MI, MS, NC, NJ, NY, OH, PA, RI, SC, TX, WA, WI, WV, and the countries of: Czech Republic, Italy, Netherlands, and New Zealand
  • Descripción del producto
    FLEXSTENT Femoropopliteal Self-Expanding Stent System. || Product Usage: || The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
  • Manufacturer
    Cordis Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de FLEXSTENT Femoropopliteal SelfExpanding Stent System (Clinical Study Protocol FSS0003 (OPEN trial)
BIOMET Comprehensive Shoulder System
  • Modelo / Serial
    Part Numbers: 113644; Use-by 2025-03-18; Lot Numbers: 127340, 182030, 349650.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US Nationwide in the states of AR, CA, IL, IN, PA, FL, KS, LA, WI, VA, MA, MD, NJ, UT, NC, TX, AL, MI, KY, OH, SD, MO, GA, NV, WA and the countries of: Europe, Canada, Japan, Chile, Korea, Mexico, New Zealand, Trinidad/Tobago, Thailand, Argentina, Australia, and China.
  • Descripción del producto
    Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components.
  • Manufacturer
    Biomet, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de BIOMET Comprehensive Shoulder System
Zimmer
  • Modelo / Serial
    00588604310 TM CR TIB SZ 3 C-H, 10MM 61746701 61746701 61746702 61752725 61759780 61769546 61776838 61776839 61770816 61785348 61797187 61792632 61792633 61797183 61797182 61797181 61797184 61820708 61820710 61820709 61833813 61839384 61833812 61844335 61844336 00588604312 TM CR TIB SZ 3 C-H, 12MM 61746699 61759781 61776842 61770815 61785349 61797192 61797191 61808975 61833814 61851747 00588604314 TM CR TIB SZ 3 C-H, 14MM 61740710 61785350 61797194 61808984 00588604317 TM CR TIB SZ 3 C-H, 17MM 61746678 61759782 61785351 00588604410 TM CR TIB SZ 4 C-H, 10MM 61733408 61752758 61752759 61759791 61759792 61776830 61770821 61770822 61792647 61792649 61792648 61803945 61803944 61803946 61809003 61809004 61820711 61828074 61828075 61833817 61833818 61839368 61839376 61839390 61857205 61857207 00588604412 TM CR TIB SZ 4 C-H, 12MM 61759793 61776831 61770818 61792651 61803950 61803951 61803952 61809002 61828076 61833821 61833822 61844350 61857204 00588604414 TM CR TIB SZ 4 C-H, 14MM 61733409 61769569 61792653 61803953 61808998 61839386 61857217 00588604417 TM CR TIB SZ 4 C-H, 17MM 61759794 61792654 61803954 00588604510 61746703 61746726 61769547 61770833 61770824 61769548 61780780 61785361 61785362 61780778 61780779 61797201 61792658 61803927 61809014 61809013 61814245 61797202 61814246 61828082 61828083 61828084 61833824 61833825 61839378 61844352 61851749 61857222 61857228 00588604512 TM CR TIB SZ 5 C-H, 12MM 61746719 61769550 61770831 61769551 61785363 61780782 61792659 61797204 61814247 61828085 61833829 61833826 61839380 61851752 00588604514 TM CR TIB SZ 5 C-H, 14MM 61770827 61785364 61797205 61792660 61828081 61844344 61857223 00588604517 TM CR TIB SZ 5 C-H, 17MM 61746709 61770825 61785365  00588604612 TM CR TIB SZ 6 C-H, 12MM 61733401 61746705 61759774 61770838 61780791 61785379 61792665 61809052 61809053 61828087 61851757 00588604614 TM CR TIB SZ 6 C-H, 14MM 61746707 61733402 61759775 61792666 61828088 61851761 00588604617 TM CR TIB SZ 6 C-H, 17MM 61759776 61785378 61809046 00588604710 TM CR TIB SZ 7 C-H, 10MM 61746730 61739891 61746729 61776818 61776819 61770845 61770846 61792672 61797212 61809055 61814252 61828089 61833834 61833832 61851764 61851765 00588604712 TM CR TIB SZ 7 C-H, 12MM 61739889 61746728 61770844 61776821 61797217 61792675 61814251 61828090 61833833 61844354 61851762 00588604714 TM CR TIB SZ 7 C-H, 14MM 61785384 61792676 61809056 00588604717 TM CR TIB SZ 7 C-H, 17MM 61776822 61785385 61809057 00588604810 TM CR TIB SZ 8 C-H, 10MM 61733390 61776826 61792688 61803937 61844355 00588604812 TM CR TIB SZ 8 C-H, 12MM 61769567 61776827 61792689 00588604814 TM CR TIB SZ 8 C-H, 14MM 61733392
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide and Foreign.
  • Descripción del producto
    TM CR TIB SZ 3 C-H, 10MM- 00588604310 || TM CR TIB SZ 3 C-H, 12 mm - 00588604312 || TM CR TIB SZ 3 C-H, 14MM - 00588604314 || TM CR TIB SZ 3 C-H, 17MM - 00588604317 || TM CR TIB SZ 4 C-H 10 MM - 00588604410 || TM CR TIB SZ 4 C-H, 12MM - 00588604412 || TM CR TIB SZ 4 C-H, 14MM - 00588604414 || TM CR TIB SZ 4 C-H, 17MM - 00588604417, 00588604510 || TM CR TIB SZ 5 C-H, 12MM - 00588604512 || TM CR TIB SZ 5 C-H, 14MM - 00588604514 || TM CR TIB SZ 5 C-H, 17MM - 00588604517, 00588604610 || TM CR TIB SZ 6 C-H, 12MM 00588604612 || TM CR TIB SZ 6 C-H, 14 MM 00588604614 || TM CR TIB SZ 6 C-H, 17 MM 00588604617 || TM CR TIB SZ 7 C-H, 10MM - 00588604710 || TM CR TIB SZ 7 C-H, 12MM - 00588604712 || TM CR TIB SZ 7 C-H, 14MM - 00588604714 || TM CR TIB SZ 7 C-H, 17MM - 00588604717 || TM CR TIB SZ 8 C-H, 10MM - 00588604810 || TM CR TIB SZ 8 C-H, 12MM - 00588604812 || TM CR TIB SZ 8 C-H, 14MM - 00588604814
  • Manufacturer
    Zimmer Trabecular Metal Technology, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Zimmer
Versys 6 inch Beaded Full Coat Plus Hip Prosthesis.
  • Modelo / Serial
    a. Item No. 00784301906 (Lot Expiration Date Before 05/31/2025);  b. Item No. 00784302106 (Lot Expiration Date Before 06/30/2025);  c. Item No. 00784302206 (Lot Expiration Date Before 01/31/2026);  d. Item No. 00784301936 (Lot Expiration Date Before 06/30/2026);  e. Item No. 00784302036 (Lot Expiration Date Before 01/31/2026);  f. Item No. 00784302136 (Lot Expiration Date Before 02/28/2025);  g. Item No. 00784302236 (Lot Expiration Date Before 07/31/2026);  h.Item No. 00784301406 (Lot Expiration Date Before 07/31/2026);  i. Item No. 00784301506 (Lot Expiration Date Before 06/30/2026);  j. Item No. 00784301606 (Lot Expiration Date Before 06/30/2026);  k. Item No. 00784301706 (Lot Expiration Date Before 06/30/2026);  l. Item No. 00784301806 (Lot Expiration Date Before 03/31/2026);  m. Item No. 00784301826 (Lot Expiration Date Before 04/30/2026);  n. Item No. 00784301926 (Lot Expiration Date Before 11/30/2025);  o. Item No. 00784302006 (Lot Expiration Date Before 11/30/2025);  p. Item No. 00784302026 (Lot Expiration Date Before 07/31/2026);  q. Item No. 00784302126 (Lot Expiration Date Before 07/31/2026);  r. Item No. 00784302226 (Lot Expiration Date Before 09/30/2025);  s. Item No. 00784301746 (Lot Expiration Date Before 07/31/2026);  t. Item No. 00784301756 (Lot Expiration Date Before 07/31/2025):  u. Item No. 00784301836 (Lot Expiration Date Before 07/31/2026);  v. Item No. 00784301846 (Lot Expiration Date Before 07/31/2026);  w. Item No. 00784301856 (Lot Expiration Date Before 06/30/2026);  x. Item No. 00784301946 (Lot Expiration Date Before 07/31/2026);  y. Item No. 00784301956 (Lot Expiration Date Before 09/30/2025);  z. Item No. 00784302046 (Lot Expiration Date Before 07/31/2026);  aa.Item No. 00784302056 (Lot Expiration Date Before 07/31/2026);  ab. Item No. 00784302146 (Lot Expiration Date Before 07/31/2026);  ac. Item No. 00784302156 (Lot Expiration Date Before 07/31/2026);  ad. Item No. 00784302246 (Lot Expiration Date Before 07/31/2026);  ae. Item No. 00784302256 (Lot Expiration Date Before 07/31/2026)
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico; and to countries of: Austria, Australia, Bahamas, Brazil, Canada, China, Dominican Republic, England, France, Germany, Israel, Japan, South Korea, Lebanon, Malaysia, Mexico, Netherlands, Panama, Singapore, Spain, Switzerland, and Thailand.
  • Descripción del producto
    Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: || a. VERSYS 6 INCH BEADED FC 19X160MM STD BODY STD NECK (Item No. 00894301906); || b. VERSYS 6 INCH BEADED FC 21X160MM STD BODY STD NECK (Item No. 00784302106); || c. VERSYS 6 INCH BEADED FC 22X160MM STD BODY STD NECK (Item No. 00784302206); || d. VERSYS 6 INCH BEADED FC STEM 19X160MM LM (Item No. 00784301936); || e. VERSYS 6 INCH BEADED FC STEM 20X160MM LM (Item No. 00784302036); || f. VERSYS 6 INCH BEADED FC STEM 21X160MM LM (Item No. 00784302136); || g. VERSYS 6 INCH BEADED FC STEM 22X160MM LM (Item No. 00784302236); || h. VERSYS 6 INCH BEADED FC 14X160MM STD BODY STD NECK (Item No. 00784301406); || i. VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK (Item No. 00784301506); || j. VERSYS 6 INCH BEADED FC 16X160MM STD BODY STD NECK (Item No. 00784301606); || k. VERSYS 6 INCH BEADED FC 17X160MM STD BODY STD NECK (Item No. 00784301706); || l. VERSYS 6 INCH BEADED FC 18X160MM STD BODY STD NECK (Item No. 00784301806); || m. VERSYS 6 INCH BEADED FC 18X160MM STD BODY EXT NECK (Item No. 00784301826); || n. VERSYS 6 INCH BEADED FC 19X160MM STD BODY EXT NECK (Item No. 00784301926); || o. VERSYS 6 INCH BEADED FC 20X160MM STD BODY STD NECK (Item No. 00784302006); || p. VERSYS 6 INCH BEADED FC 20X160MM STD BODY EXT NECK (Item No. 00784302026); || q. VERSYS 6 INCH BEADED FC 21X160MM STD BODY EXT NECK (Item No. 00784302126); || r. VERSYS 6 INCH BEADED FC 22X160MM STD BODY EXT NECK (Item No. 00784302226); || s. VERSYS 6 INCH BEADED FC 17X160MM LM BODY XEXT NECK (Item No. 00784301746); || t. VERSYS 6 INCH BEADED FC 17X160MM LM BODY EXT NECK (Item No. 00784301756 || u. VERSYS 6 INCH BEADED FC STEM 18X160MM LM (Item No. 00784301836); || v. VERSYS 6 INCH BEADED FC 18X160MM LM BODY XEXT NECK (Item No. 00784301846); || w. VERSYS 6 INCH BEADED FC 18X160MM LM BODY EXT NECK (Item No. 00784301856); || x. VERSYS 6 INCH BEADED FC 19X160MM LM BODY XEXT NECK (Item No. 00784301946); || y. VERSYS 6 INCH BEADED FC 19X160MM LM BODY EXT NECK (Item No. 00784301956); || z. VERSYS 6 INCH BEADED FC 20X160MM LM BODY XEXT NECK (Item No. 00784302046); || aa. VERSYS 6 INCH BEADED FC 20X160MM LM BODY EXT NECK (Item No. 00784302056); || ab. VERSYS 6 INCH BEADED FC 21X160MM LM BODY XEXT NECK (Item No. 00784302146); || ac. VERSYS 6 INCH BEADED FC 21X160MM LM BODY EXT NECK (Item No. 00784302156); || ad. VERSYS 6 INCH BEADED FC 22X160MM LM BODY XEXT NECK (Item No. 00784302246); || ae. VERSYS 6 INCH BEADED FC 22X160MM LM BODY EXT NECK (Item No. 00784302256) || Components of the system are intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia, and/or total knee in cases that require extensive resection and restoration.
  • Manufacturer
    Zimmer Biomet, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Versys 6 inch Beaded Full Coat Plus Hip Prosthesis.
Krupin Eye Valve
  • Modelo / Serial
    P/N 6003, Serial numbers: 10671A through 10714A; 10807A through 10813A; 108866A through 10905A
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide, Canada, Columbia, Turkey, & The Netherlands
  • Descripción del producto
    Krupin Eye Valve, P/N 6003
  • Manufacturer
    Eagle Vision Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Krupin Eye Valve
Depuy Preservation Uni Knee
  • Modelo / Serial
    Lot W75BT4.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide.
  • Descripción del producto
    Depuy Preservation Uni Knee All Poly Tibia, RM/LL, Sz 4, 11.5 mm, sterile; Product Code/REF 1498-11-410.
  • Manufacturer
    Depuy Orthopaedics, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Depuy Preservation Uni Knee
Depuy Preservation Uni Knee
  • Modelo / Serial
    Lots W85DF4, W85DG4, W85DJ4, W85DL4 and W85DM4.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide.
  • Descripción del producto
    Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 5, 7.0 mm, sterile; Product code/REF 1498-12-506.
  • Manufacturer
    Depuy Orthopaedics, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Depuy Preservation Uni Knee
iPulse Circulatory Support System
  • Modelo / Serial
    Serial numbers: SC1000, SC1001, SC1003 - SC1010, SC1014 - SC1023, SC1025 - SC1070, SC1072 - SC1081, SC1083, SC1084, and SC1089
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Domestic: MA, MI, SC, NY, NJ, OH, CA, PA, AR, MI, MD, CT, IL, WI, TX, NJ, TN, IN, MI, DE, FL, IA, WA, KY, and WV Foreign: Germany, Greece, Italy, Latvia, Spain, and Turkey
  • Descripción del producto
    iPulse Circulatory Support System || Catalog number: 0036-0010 || The iPulse System Console is a multi-purpose mechanical circulatory support system used to support patients suffering from acute cardiovascular failure. The iPulse console can be used to drive exclusively one of two classes of therapeutic devices: either pneumatically actuated Ventricular Assist Devices (VADs) for total circulatory support, or (i.e., non-simultaneously) an intra-aortic balloon (IAB) catheter for counter-pulsation therapy.
  • Manufacturer
    Abiomed, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de iPulse Circulatory Support System
Device Recall SOL SYS L 9IN CALC 2.25/15.0
  • Modelo / Serial
    Product Code: 157225150 and Lot codes: 107076, X4SE71000, 117308, X4SE7A000, A38B51000, X4SE7B000, AV3DR1000, YA9BN1000, B2DB11000, YF3E71000, BA4GR1000, YF3E7A000, BA4GRA000, YG4AF1000, BC4HR1000, Z47HE1000, C49A61000, Z4RJE1000, C6ACN1000, Z81H61000, C77A61000, CD1ER1000 CD1ERA000, CK3E21000, CK3E2A, CY4GB1000, DX7J21000, DX7J2A000, E3FH61000, E4HB41000, E5DDA1000, E6BKR1, EJ4EH1000, EW9J61000, X32HH1000, X43C71000, X43C91000, and X43C9B000.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR
  • Descripción del producto
    SOL SYS L 9IN CALC 2.25/15.0 || Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. || Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
  • Manufacturer
    DePuy Orthopaedics, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall SOL SYS L 9IN CALC 2.25/15.0
Device Recall Free Lock Femoral Fixation System
  • Modelo / Serial
    60611022 60611024 60619085 60598271 60598275 60628437 60582010 60625420 60629729 60630044 60630089 60632485 60628439 60630043 60630090 60630091 60630093 60630095 60630098 60632496 60632513 60629728 60630092 60630094 60630096 60632497 60632504 60632506 60646243 60632516 60632527 60646247 60632505 60632514 60646241 60646245 60646256 60648988 60648990 60630045 60646250 60646257 60646260 60646261 60630097 60646251 60664579 60666551 60666553 60630101 60664586 60664589 60664591 60666539 60666552 60666554 60664584 60666570 60646255 60664594 60666550 60666568 60666555 60666557 60666567 60666540 60666544 60666546 60666547 60666548 60664611 60666569 60664616 60666542 60666543 60666556 60666560 60679361 60679362 60679363 60666545 60678765 60678768 60678771 60679351 60679353 60679364 60679345 60679348 60679359 60685057 60666558 60666561 60679349 60679354 60679357 60685086 60685089 60679352 60679360 60666541 60674432 60685033 60685035 60685036 60685038 60685060 60685081 60679355 60685083 60685031 60685072 60699482 60685030 60699487 60699488 60704350 60704351 60704355 60704352 60699489 60704353 60704346 60704354 60704345 60704347 60704348 60704357 60704358 60704360 60714919 60704349 60704359 60685034 60704356 60704361 60704363 60714925 60714920 60714928 60714922 60714924 60704362 60704364 60704365 60714918 60714923 60714926 60714927 60714932 60714934 60714935 60714936 60714965 60714966 60714967 60714968 60726367 60714933 60726368 60726329 60726365 60674435 60726330 60726332 60726364 60726324 60726327 60726328 60726366 60746152 60726320 60726331 60726369 60746137 60746188 60746189 60746190 60746266 60746268 60726321 60746183 60746280 60754394 60726322 60726323 60726370 60746134 60746269 60746273 60746265 60746193 60746270 60763198 60746271 60699490 60726361 60746151 60763201 60763202 60763203 60763204 60763213 60746281 60763199 60763212 60746186 60746267 60746274 60763210 60746185 60746191 60746272 60763197 60763205 60763206 60699483 60746153 60763211 60746184 60763196 60779869 60779870 60779871 60779873 60779874 60779875 60779880 60779881 60779882 60779868 60779876 60779878 60779879 60787026 60787027 60787028 60787032 60787146 60779877 60787024 60787030 60787031 60787033 60787034 60787025 60787035 60787036 60787038 60787039 60787041 60787118 60787040 60787042 60787043 60787120 60787122 60787129 60803574 60787131 60787135 60787178 60787141 60803571 60803572 60803573 60803575 60803579 60787126 60787130 60803580 60812093 60787029 60803576 60812092 60812096 60812097 60812098 60803577 60787182 60812095 60812099 60812102 60812106 60812101 60820608 60812100 60812104 60812105 60820607 60820609 60820613 60820618 60820623 60812103 60820611 60820614 60820620 60820615 60820616 60820628 60820577 60820621 60820624 60820631 60820634 60820626 60820715 60820601 60820633 60820718 60812094 60820632 60820687 60820690 60831411 60820698 60820829 60820686 60820695 60820697 60845775 60820716 60845773 60845769 60845772 60868454 60868456 60845770 60868462 60868464 60874079 60874080 60874081 60874082 60877483 60877486 60874078 60877482 60877485 60877488 60885159 60885156 60885157 60885161 60890078 60874086 60879858 60885155 60885158 60885162 60885164 60885166 60885168 60897286 60897287 60897288 60897290 60897289 60897291 60897292 60897293 60897294 60897295 60900737 60900738 60902831 60902834 60902827 60902833 60903904 60905698 60905699 60911339 60911334 60911336 60911338 60911342 60911337 60918557 60918558 60918559 60903913 60911340 60918560 60918568 60923650 60923651 60923652 60923649 60923653 60923654 60820627 60931160 60931162 60932383 60932384 60932391 60932382 60932386 60932388 60932390 60938414 60911335 60932389 60931163 60938403 60938406 60938408 60938415 60943334 60938416 60943333 60943335 60943336 60943337 60944518 60944513 60944514 60944515 60944516 60944517 60944520 60944521 60944519 60959967 60959968 60944512 60959970 60959971 60962113 60959969 60959973 60962115 60962120 60962129 60968725 60968727 60972786 60959972 60962101 60962102 60962109 60962122 60962137 60962155 60968736 60972788 60972790 60962106 60962124 60968726 60962135 60968730 60972789 60972791 60972796 60714969 60911333 60943338 60972792 60968728 60997749 60997750 60998281 60998283 60998285 60998282 60997748 60997751 60998284 60998286 61004981 61004983 61004986 61005004 61004984 61004989 61009048 61010334 61010340 61010341 60972798 60998289 61004999 61005002 61010339 61011701 61011703 61011699 61009470 61011698 60918569 60968723 60962157 61020314 60998288 61020312 61004997 60968734 60968746 61031797 61031801 61031803 61031805 61020324 61031795 61037481 61037482 61037483 60972795 61031792 61020306 61041080 61041082 61041083 61041085 60855078 61031810 61037486 61041079 61041084 61059148 61059150 61041087 61062350 61027505 61059147 61059149 61059152 61062345 61062356 61027513 61062359 61027495 61041081 61059151 61062344 61062346 61066536 61076071 61076073 60855079 61027493 61037485 61076074 61066535 61076065 61067766 61076072 61076076 61086815 61027512 61041088 61066537 61067767 61076066 61076075 61076078 61086813 61086812 61086816 61086817 61086821 61086844 61086847 61027514 61076077 61076069 61086835 61092191 61092203 61092206 61092210 61027515 61086839 61092208 61092209 61092213 61092212 61076067 61092215 61027517 61092218 61104845 61104846 61104847 61104848 61109162 61109163 61104849 61109161 61109164 61109165 61109166 61109167 61109157 61109158 61109159 61109160 61114128 61114130 61114136 61011702 61109156 61114126 61114127 61114134 61081609 61109169 61118965 61118969 61105464 61114117 61118962 61118968 61118971 61118973 61076079 61081610 61105466 61114105 61118967 61118970 61118972 61076070 61081611 61081612 61118963 61118975 61120932 61120933 61120934 61081613 61128190 61114104 61130026 61130024 61130029 61132952 61132953 61132954 61120935 61128191 61136347 61136349 61136350 61136351 61136348 61105467 61130027 61136352 61140153 61140154 61140163 61140164 61140165 61140166 61140152 61140174 61148121 61148125 61148126 61132955 61140155 61148123 61148124 61148128 61151203 61151204 61151199 61151202 61148117 61151201 61151206 61009480 61009471 61009474 61009475 61009476 61009477 61009482 61151196 61151198 61151207 61009473 61011704 61151189 61151190 61151205 61151208 61009472 61163260 61163262 61163267 61163268 61163281 61163283 61169406 61009481 61163270 61169405 61169407 61169408 61169409 61163272 61169410 61169414 61179734 61179740 61163264 61179732 61179733 61179743 61120931 61179744 61179749 61009479 61128192 61163289 61163290 61169413 61179735 61179738 61179741 61179742 61179745 61179746 61179747 61179748 61009478 61179739 61197964 61118966 61163288 61179736 61179737 61179750 61197960 61197961 61197962 61197963 61197965 61197966 61197967 61197968 61197969 61198427 61198431 61198437 61198438 61198434 61198435 61198426 61203364 61203367 61203368 61203365 61198436 61203360 61203362 61203366 61140171 61203363 61198411 61198415 61198429 61114137 61198420 61216922 61244920 61198406 61198414 61198417 61216921 61216924 61216925 61198428 61198433 61198408 61198409 61198413 61198416 61198422 61216923 61216926 61216928 61216932 61222983 61222986 61216929 61216931 61198407 61198412 61198418 61203361 61216919 61216920 61216930 61222985 61151193 61222988 61140161 61216918 61198410 61216917 61222982 61222989 61222993 61222981 61222987 61222991 61222995 61223001 61228324 61228327 61228331 61222997 61163278 61198425 61228329 61228332 61228334 61246001 61222998 61228323 61228325 61228338 61143395 61151194 61151210 61198424 61216927 61228328 61228330 61228333 61228336 61228337 61245978 61245979 61246055 61228326 61245980 61245981 61245983 61245984 61245987 61245991 61245993 61246023 61246054 61246056 61246060 61294826 61228335 61245986 61245982 61274517 61274518 61293477 61076068 61245975 61264716 61264721 61264729 61245977 61264718 61264719 61274514 61245988 61245992 61245994 61264722 61264724 61274515 61245989 61245990 61274516 61294824 61245985 61264717 61286873 61304464 61245976 61309050 61309051 61311407 61286856 61304466 61316196 61304465 61309053 61311406 61316195 61316197 61245999 61264726 61294827 61311410 61286854 61316194 61294828 61309344 61286857 61309345 61342272 61309348 61326721 61286872 61344224 61347115 61341981 61316181 61347117 61352929 61357161 61357157 61316180 61340965 61340969 61347116 61347119 61348695 61348696 61348697 61352932 61260780 61260782 61264733 61340964 61340966 61341979 61341980 61347122 61348694 61348699 61352930 61352931 61357155 61359992 61316182 61316192 61340963 61340968 61347112 61347118 61357158 61357160 61364137 61340967 61347114 61364135 61364138 61357156 61347120 61377325 61377326 61382042 61382044 61386061 61386063 61382043 61387470 61382041 61386062 61387471 61387473 61382946 61391478 61391477 61391479 61391480 61260779 61357163 61402002 61402003 61412170 61412171 61412172 61408294 61417095 61417097 61417096 61420329 61420331 61420333 61420334 61420330 61420339 61420341 61427109 61427345 61427346 61427110 61427111 61427112 61427347 61428555 61260778 61431745 61432416 61441995 61446259 61432413 61433929 61440686 61432415 61432417 61437986 61437987 61440255 61440256 61440680 61440681 61440687 61433930 61447015 61449272 61465687 61453110 61457771 61464978 61464979 61464980 61464981 61432418 61464983 61465688 61464982 61482341 61473799 61473801 61473802 61482340 61484357 61484358 61484359 61484360 61473798 61484356 61493896 61493897 61499396 61499397 61499393 61499395 61503009 61506161 61506162 61506160 61375159 61375160 61375161 61509877 61509878 61512222 61512223 61512224 61516364 61516365 61375163 61509879 61511594 61512535 61512536 61375167 61523981 61529227 61516746 61516747 61516748 61523576 61523577 61523578 61523579 61529229 61533692 61516749 61533695 61534555 61538709 61534556 61523580 61533694 61533693 61533696 61538710 61538711 61538712 61538708 61538713 61538714 61542595 61542594 61542602 61551560 61551561 61558657 61551558 61551563 61558656 61558658 61558659 61565473 61565474 61565475 61565476 61565477 61565478 61565479 61565472 61565480 61578705 61584964 61584965 61584966 61565471 61578707 61578702 61578706 61584962 61596981 61596982 61596984 61596977 61596978 61596979 61596980 61590986 61607684 61607685 61596976 61621780 61621798 61590987 61607687 61613170 61621788 61621791 61621796 61621799 61621804 61607686 61621811 61635175 61645758 61621778 61621818 61640874 61640876 61640880 61621786 61621824 61621829 61621784 61640877 61640878 61640879 61640882 61640875 61640881 61640884 61659697 61659698 61659695 61596983 61640883 61659696 61659705 61659776 61659699 61659726 61659774 61659775 61659765 61672108 61672109 61672111 61681374 61672112 61672115 61677255 61677273 61677278 61677279 61677280 61677282 61677299 61677304 61681367 61681373 61681375 61681376 61681390 61681397 61681411 61677268 61688187 61688188 61677303 61684790 61677294 61677292 61677296 61677297 61677298 61677302 61684789 61677290 61681414 61677281 61677289 61677291 61677305 61681412 61681413 61681419 61681420 61693790 61716245 61677301 61681416 61681417 61681418 61681421 61693785 61677287 61729212 61738441 61681388 61681422 61681423 61693774 61693787 61693792 61693794 61681380 61693772 61693775 61677285 61677286 61681401 61681407 61745100 61681408 61681409 61681410 61745109 61681384 61681402 61693777 61748731 61749793 61681404 61681406 61681403 61745914 61753017 61753020 61681398 61681399 61716224 61716225 61753018 61681405 61693783 61716226 61716227 61716228 61748727 61748729 61748732 61758093 61758102 61748918 61748919 61758130 61780109 61753024 61758077 61748730 61753039 61758104 61758121 61758122 61758128 61782895 61782896 61808360 61808433 61808436 61808819 61815573 61808359 61808431 61808438 61758101 61824626 61824614 61835476 61839354 61842559 61867375 61867376 61867382 61886392 61929829 61964337 61964341 61964343 61979181 62011138 62016616 62016620 62038668 62042752 62045192 62049341 62049342 62042565 62045199 62042371 62053151 62029920 62036974 62049336 62063861 62050763 62073625 62086487 62086493 62076935 62080175 62076944 62116683 62116688 62146230 62146235 62152755 62091261 62161691 62193549 62315753 62315762 62315764 62315765 62315759 62320741 62330816 62330839 37107670 62342071 62342227 62342232
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: US Nationwide (including PR and USVI), and countries of: Israel, Argentina, Brazil, France, Mexico, Saudi Arabia, Beirut, China, Korea, San Salvador, Honduras, Canada, Australia, Switzerland, Germany, Arab Emirates, UK, Belgium, Egypt, Spain, France, Italy, Iran, Lebanon, Jordan, Iraq, Canary Islands.
  • Descripción del producto
    VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short low profiles, several holes/length combinations (2/54, 3/70, 4/86, 5/102, 6/118) and several angles (130, 135, 140, 145 and 150). Item codes starting with 00-1193-130, 00-1193-135, 00-1193-140, 00-1193-145, 00-1193-150. orthopedic implant.
  • Manufacturer
    Zimmer, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Free Lock Femoral Fixation System
Device Recall SC2316, Distal Femoral Augment with Screw
  • Modelo / Serial
    Part number SC2316-3-5 with lot number 22389-111609. Part number SC2316-4-5 with lot number 22587-111609. Part number SC2316-5-5 with lot number 23214-111609.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including TX, VA, OK, and PA
  • Descripción del producto
    SC2316, Distal Femoral Augment with Screw || Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions.
  • Manufacturer
    Stelkast Co
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall SC2316, Distal Femoral Augment with Screw
Device Recall Synthes Trochanteric Fixation Nail
  • Modelo / Serial
    Part 456.475S, lot # 7121831 and Part 456.637S, lot #7121832, expiration 11/30/21.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including WA, FL, LA, TX, GA, IN, OH, CA, MI, and PA.
  • Descripción del producto
    Synthes Trochanteric Fixation Nail || As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.
  • Manufacturer
    Synthes USA HQ, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Synthes Trochanteric Fixation Nail
Device Recall Suture, Nonabsorbable, Synthetic, Polyamide
  • Modelo / Serial
    Product Code: 1154654, Lot number: 02K0801212
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
  • Descripción del producto
    Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, || Product Usage: || Non-absorbable polyamide surgical suture is a non-absorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation.
  • Manufacturer
    Teleflex Medical
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Suture, Nonabsorbable, Synthetic, Polyamide
Device Recall Allez Spine Laguna Pedicle Screw System
  • Modelo / Serial
    Catalog # LG-PR0650
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide to AZ, CA, CO & UT
  • Descripción del producto
    Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 50mm, Non-winged, Catalog # LG-PR0650
  • Manufacturer
    Allez Spine, LLC
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Allez Spine Laguna Pedicle Screw System
Device Recall KyphX HVR Bone Cement
  • Modelo / Serial
    Lot Numbers: EL15106, EL15406, EL15706, EL16006, EL16406, EL16506, EL16806, EL17006, EL17307, EL17507, EL17607, EL17707, EL17807, EL18007, EL18307, EL18407, EL18707, EL18907, EL19207, EL19507, EL19807, EL20007, EL20107, EL20307, EL20407, EL20507, EL20607, EL20808, EL20908, EL21008, EL21208, EL21308, EL21608, EL21708, EL21908, EL22008, EL22108, EL22308, EL22908, EL23008, EL23508, EL23608, EL23708, EL24008, 24108, EL24208, EL24408, EL24508, EL24608, EL25008, EL25108, EL25408, EL25508, EL26409, EL26509
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    USA including states of: AL, AR, AZ, CA, CO, DC, FL, GA, IA, IN, KY, MA, MD, MO, MT, NC, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV; and countries including: Argentina, Austria, Belgium, Brazil, Canada, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Ivory Coast, Jordan, Kuwait, Lebanon, Luxembourg, Lybia, Malaysia, Malta, Mexico, Morocco, Netherlands, New Caledonia, Norway, Panama, Philippines, Poland, Portugal, Puerto Rico, Reunion, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Turkey, United Arab Emirates, United Kingdom and Vietnam.
  • Descripción del producto
    Medtronic brand KyphX HV-R Bone Cement, a polymethyl bone cement consisting of a quantity of powder (20 g) and a volume of liquid (10 ml/9 g) mixed in a Kyphon mixer for up to two minutes. Model Number: CO1A; Manufactured by Elmdown LTD, London, England, for Medtronic Spine LLC, Sunnyvale, CA. || Product is a medical device used during balloon kyphoplasty to cement structures in fractured vertebral bodies.
  • Manufacturer
    Medtronic Spine LLC, formerly Kyphon Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall KyphX HVR Bone Cement
Device Recall SpeedLink 6.0 Transverse Connector
  • Modelo / Serial
    10ZF, 12LX, 14ML, 16RD, 30NS, 35HS, 41HB, 44KQ, 5PC, 6AY, 6AZ, 6BA, 6BB, 7DZ and , 8BP.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    The devices are contained in implant cases stocked by Zimmer spine and made available to the Zimmer sales force for surgeries. They are not in general distribution.
  • Descripción del producto
    SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S
  • Manufacturer
    Zimmer Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall SpeedLink 6.0 Transverse Connector
Device Recall Turon Humeral Head Trials
  • Modelo / Serial
    Part numbers: 804-05-021, 804-05-022, 804-05-023, 804-05-024, 804-05-025, 804-05-026, 804-05-027, 804-05-028, 804-05-029, 804-05-030, 804-05-031, 804-05-032, 804-05-033, 804-05-034,  804-05-035, 804-05-036, 804-05-037, 804-05-038, 804-05-039, 804-05-040, 804-05-041, 804-05-042, 804-05-043, 804-05-044, 804-05-045
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    TX, FL, SC, GA
  • Descripción del producto
    Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical
  • Manufacturer
    Encore Medical, Lp
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Turon Humeral Head Trials
Superstat Modified Collagen Hemostatic Sponge
  • Modelo / Serial
    Lot# R1018D, SSM02D, SSN12D .
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, Thailand, Mexico, Canada, Pakistan, Israel, Greece, Serbia, Canda, Isle of Man, Nova Scotia, and Singapore.
  • Descripción del producto
    Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30. || For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
  • Manufacturer
    Superstat Corp
  • 1 Event
    • Retiro De Equipo (Recall) de Superstat Modified Collagen Hemostatic Sponge
Zimmer Gender Solutions Natural Knee Flex System, Prolong Articular Surface,
  • Modelo / Serial
    Lots 60932817, 60947726, 60947740, 60954160, 60958280, 60964468, 60975037, 60981811, 60987827, 60988226, 60992959, 60992960, 60992961, 61001553, 61005440, 61017701, 61027885, 61036350, 61036354, 61045085, 61051480, 61064807, 61069417, 61075244, 61078759, 61085878, 61096363, 61101462, 61106565, 61114168 and 61117040.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- United States, Austria, Belgium, France, Germany, Japan, Spain and Switzerland.
  • Descripción del producto
    Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, right, 13 MM height, for use with baseplate size 1 or 2, sterile, Zimmer, Warsaw, IN; REF 00-5424-021-13. || The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.
  • Manufacturer
    Zimmer Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Zimmer Gender Solutions Natural Knee Flex System, Prolong Articular Surface,
Synthes Spiral Blade Component of the Synthes Modular Blade Plate System
  • Modelo / Serial
    All lots of Part Number: 02.122.595, 95mm Spiral Blade, 14mm, Right
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including AL, CA, GA, IA, IL, IN, MA, MI, MS, NC, NJ, NV, OH, PA, SC, SD, TN, and WV.
  • Descripción del producto
    02.122.595, 95mm Spiral Blade, 14mm, || Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System || For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
  • Manufacturer
    Synthes USA (HQ), Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Synthes Spiral Blade Component of the Synthes Modular Blade Plate System
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Aviso

Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.

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