Item Number: 00585205219, Lot Number Expiry Date Before: March 2027

Orthopedic Devices

2

Yes

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

Segmental fluted stem, 19x190mm str, Sterile, || Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants

Item Number: 00784301708, Lot Number Expiry Date Before: July 2026

Orthopedic Devices

2

Yes

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

Por fullct fem st 17x200mm, Sterile,

All Serial Numbers

Cardiovascular Devices

3

Yes

US Nationwide Distribution

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).

Item Number: 00-7843-013-18 Lot Number: 62158840

Orthopedic Devices

2

Yes

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.

VERSYS 7.5 INCH BEADED FC REV 13.5X190MM STRAIGHT || Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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.

Cardiovascular Devices

3

Yes

Nationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America

Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker, models SS103, SS106, SS203, SS303

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

Cardiovascular Devices

3

Yes

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

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.

Part Numbers: 113644; Use-by 2025-03-18; Lot Numbers: 127340, 182030, 349650.

Orthopedic Devices

2

Yes

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.

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.

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

Orthopedic Devices

2

Yes

Nationwide and Foreign.

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

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)

Orthopedic Devices

2

Yes

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.

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.

P/N 6003, Serial numbers: 10671A through 10714A; 10807A through 10813A; 108866A through 10905A

Ophthalmic Devices

2

Yes

Nationwide, Canada, Columbia, Turkey, & The Netherlands

Krupin Eye Valve, P/N 6003

Lot W75BT4.

Orthopedic Devices

3

Yes

Nationwide.

Depuy Preservation Uni Knee All Poly Tibia, RM/LL, Sz 4, 11.5 mm, sterile; Product Code/REF 1498-11-410.

Lots W85DF4, W85DG4, W85DJ4, W85DL4 and W85DM4.

Orthopedic Devices

3

Yes

Nationwide.

Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 5, 7.0 mm, sterile; Product code/REF 1498-12-506.

Serial numbers: SC1000, SC1001, SC1003 - SC1010, SC1014 - SC1023, SC1025 - SC1070, SC1072 - SC1081, SC1083, SC1084, and SC1089

Cardiovascular Devices

3

Yes

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

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.

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.

Orthopedic Devices

2

Yes

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

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.

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 61067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1565480 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

Orthopedic Devices

2

Yes

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.

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.

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.

Orthopedic Devices

2

Yes

Nationwide Distribution including TX, VA, OK, and PA

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.

Part 456.475S, lot # 7121831 and Part 456.637S, lot #7121832, expiration 11/30/21.

Orthopedic Devices

2

Yes

Nationwide Distribution including WA, FL, LA, TX, GA, IN, OH, CA, MI, and PA.

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.

Product Code: 1154654, Lot number: 02K0801212

General and Plastic Surgery Devices

2

Yes

Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland

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.

Catalog # LG-PR0650

Orthopedic Devices

2

Yes

Nationwide to AZ, CA, CO & UT

Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 50mm, Non-winged, Catalog # LG-PR0650

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

Orthopedic Devices

2

Yes

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.

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.

10ZF, 12LX, 14ML, 16RD, 30NS, 35HS, 41HB, 44KQ, 5PC, 6AY, 6AZ, 6BA, 6BB, 7DZ and , 8BP.

Orthopedic Devices

2

Yes

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.

SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S

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

Orthopedic Devices

2

Yes

TX, FL, SC, GA

Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical

Lot# R1018D, SSM02D, SSN12D .

General and Plastic Surgery Devices

3

Yes

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.

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

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.

Orthopedic Devices

2

Yes

Worldwide Distribution -- United States, Austria, Belgium, France, Germany, Japan, Spain and Switzerland.

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.

All lots of Part Number: 02.122.595, 95mm Spiral Blade, 14mm, Right

Orthopedic Devices

2

Yes

Nationwide Distribution including AL, CA, GA, IA, IL, IN, MA, MI, MS, NC, NJ, NV, OH, PA, SC, SD, TN, and WV.

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.