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  • Dispositivo 1211
  • Fabricante 31827
  • Evento 5885
  • Implante 4142
Zimmer Trabecular
  • Modelo / Serial
    Lots 60457716 and 60492624.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide and Australia.
  • Descripción del producto
    Zimmer Trabecular metal shoulder instrumentation proximal provisional humeral stem, 48 degrees, 9/10 mm diameter, nonsterile; REF 4309-18-10, Catalog no. 00-4309-018-10.
  • Manufacturer
    Zimmer Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Zimmer Trabecular
Zimmer TM400 Broach Handle
  • Modelo / Serial
    All lots.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide, Austria, Australia, Belgium, Canada, Finland, Germany, Greece, Korea, South Africa, Sweden, Switzerland, Taiwan and the United Kingdom.
  • Descripción del producto
    Zimmer TM-400 Broach Handle; Part No. 96-210-10001. The product is a surgical instrument for use in conjunction with Zimmer TM-400 Trabecular Metal implants during spinal surgery. || The Broach Handle threads onto various broaches and trial implants. The handle with these broaches or trials attached is used to prepare and measure a vertebral space to accept a TM-400 Trabecular Metal implant.
  • Manufacturer
    Zimmer Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Zimmer TM400 Broach Handle
Zimmer TiTLE2 Polyaxial Spinal System
  • Modelo / Serial
    L75118
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AL, AZ, CA, CO, FL, MI, MN, NC, PA, OH, OK, TN, TX, WA, and WI.
  • Descripción del producto
    TiTLE 2 Polyaxial Spinal System, Counter Torque Assembly Tool, Part ET1132-01, Zimmer, Warsaw, IN. || The Zimmer Title 2 counter torque assembly tool is a reuseable, non- implantable surgical tool that is provided as part of a the device system for use as a secondary option for compression and distraction of the construct assembly and initial tightening of set screws. The instrument is designed to provide equal torque in the opposite direction to the torque that is being applied to the cap screw during tightening.
  • Manufacturer
    Zimmer Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Zimmer TiTLE2 Polyaxial Spinal System
Zimmer NexGen PRI Femoral Impactor Head
  • Modelo / Serial
    Item No. 00-5901-032-00  Lots: 56572845 56574197 56574534 56574775 56575838 56573249 56574198 56574535 56575827 56575839 56573282 56574325 56574536 56575828 56575840 56573283 56574326 56574604 56575829 56576089 56573284 56574327 56574605 56575830 56576090 56573285 56574328 56574606 56575831 56576091 56574130 56574329 56574607 56575832 56576421 56574135 56574530 56574608 56575833 56576429 56574136 56574531 56574617 56575836 56576431 56574137 56574532 56574714 56575837 56576544 56574196 56574533 56574774
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US (nationwide) including PR and the states of AL, AZ, CA, CO, FL, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, and the countries of Canada, Korea, Singapore, Australia, Japan, Malaysia, India, Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Iceland, Iran, Israel, Italy, Norway, Russian Federation, Saudi Arabia, South America, Spain, Sweden, Switzerland, United Kingdom, and United Arab Emirates.
  • Descripción del producto
    PRI Femoral Impactor Block for knee prosthesis surgery. || Orthopedic Manual Surgical Instrument
  • Manufacturer
    Zimmer, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Zimmer NexGen PRI Femoral Impactor Head
Zimmer brand fracture blade plate instrument Chisel, 95 degree, small; assembly part 4705-03-10, ...
  • Modelo / Serial
    Chisel lot number 60048084.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide and Canada.
  • Descripción del producto
    Zimmer brand fracture blade plate instrument Chisel, 95 degree, small; assembly part 4705-03-10, catalog number 00-4705-003-10.
  • Manufacturer
    Zimmer Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Zimmer brand fracture blade plate instrument Chisel, 95 degree, small; assembly part 4705-03-10, catalog number 00-4705-003-10.
Zimmer Ardis Interbody Inserter
  • Modelo / Serial
    Model: Part Number 3256-01, Affected: All
  • Clasificación del producto
    Orthopedic Devices
  • Manufacturer
    Zimmer Spine Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Zimmer Ardis Interbody Inserter
X-Celerate Universal Block Pegless Size #3
  • Modelo / Serial
    All lot codes since 1998; Catalog Number 8000-3303
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Products were distributed worldwide.
  • Descripción del producto
    X-Celerate Universal Block Pegless Size #3, || Non Sterile;
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de X-Celerate Universal Block Pegless Size #3
Xcelerate Patella Reamer Shaft Assembly and Adapter
  • Modelo / Serial
    Product no. 8001-1702; Lot codes: MCYL30A, and MCYL30B.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Class II Recall - Worldwide Distribution --- including USA and Canada, United Kingdom.
  • Descripción del producto
    Xcelerate Patella System Reamer Shaft Assembly; || Non-Sterile; || Howmedica Osteonics Corp., || 325 Corporate Drive; || Mahwah, NJ 07430 || Authorized representative in Europe: || Stryker France ZAC Satolas Green Pusignan || Cedex, France
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Xcelerate Patella Reamer Shaft Assembly and Adapter
VerSys Hip System Provisional Femoral Head 12/14 Neck Taper
  • Modelo / Serial
    All lots distributed from lot 69998600 (2/20/1996) to present
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries of: Asia, Barbados, Canada, Europe, Mexico, Puerto Rico, San Juan, and South America.
  • Descripción del producto
    00789504001 VerSys Femoral Head Provisional 40mm -3.5 || 00789504002 VerSys Femoral Head Provisional 40mm +0 || 00789504003 VerSys Femoral Head Provisional 40mm +3.5 || 00789504004 VerSys Femoral Head Provisional 40mm +7 || 00789504005 VerSys Femoral Head Provisional 40mm +10.5 || The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty
  • Manufacturer
    Zimmer, Inc.
  • 6 Events
    • Retiro De Equipo (Recall) de VerSys Hip System Provisional Femoral Head 12/14 Neck Taper
    • Retiro De Equipo (Recall) de VerSys Hip System Provisional Femoral Head 12/14 Neck Taper
    • Retiro De Equipo (Recall) de VerSys Hip System Provisional Femoral Head 12/14 Neck Taper
    • Retiro De Equipo (Recall) de VerSys Hip System Provisional Femoral Head 12/14 Neck Taper
    • Retiro De Equipo (Recall) de VerSys Hip System Provisional Femoral Head 12/14 Neck Taper
    • Retiro De Equipo (Recall) de VerSys Hip System Provisional Femoral Head 12/14 Neck Taper
VerSys Femoral Head Provisional
  • Modelo / Serial
    All lots distributed from lot 69998600 (2/20/1996) to present
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea.
  • Descripción del producto
    00789502601 VerSys Femoral Head Provisional 26mm -3.5 || 00789502602 VerSys Femoral Head Provisional 26mm +0 || 00789502603 VerSys Femoral Head Provisional 26mm +3.5 || 00789502604 VerSys Femoral Head Provisional 26mm +7 || 00789502605 VerSys Femoral Head Provisional 26mm +10.5 || 12/14 Neck Taper || The provisional heads replicate final femoral implant geometry y and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
  • Manufacturer
    Zimmer, Inc.
  • 2 Events
    • Retiro De Equipo (Recall) de VerSys Femoral Head Provisional
    • Retiro De Equipo (Recall) de VerSys Femoral Head Provisional
VerSys
  • Modelo / Serial
    All lots distributed from lot 69998600 (2/20/1996) to present
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea.
  • Descripción del producto
    00789502801 VerSys Femoral Head Provisional 28mm -3.5 || 00789502802 VerSys Femoral Head Provisional 28mm +0 || 00789502803 VerSys Femoral Head Provisional 28mm +3.5 || 00789502804 VerSys Femoral Head Provisional 28mm +7 || 00789502805 VerSys Femoral Head Provisional 28mm +10.5 || 12/14 Neck Taper || The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
  • Manufacturer
    Zimmer, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de VerSys
Various Polyethylene Implants
  • Modelo / Serial
    Various Polyethylene ImplantsMultiple Item and Lot NumbersARTG Numbers: 98451, 144584, 219196, 219825, 219841, 219858, 223027,223028, 225307, 226020, 227968, 246654, 249554 and 272677
  • Clasificación del producto
    Orthopedic Devices
  • Manufacturer
    Zimmer Biomet Pty Ltd
  • 1 Event
    • Retiro De Equipo (Recall) de Various Polyethylene Implants
VANGUARD TOTAL KNEE SYSTEM - DCM - PS PLUS TIBIAL BEARINGS
  • Modelo / Serial
    Model Catalog: 183740 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: XL-105925 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: XL-105924 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: XL-105923 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: XL-105914 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: XL-105903 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: XL-105833 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 141514 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 189080 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 189062 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 189040 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 189020 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 11-165236 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 11-165232 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 11-165226 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model
  • Clasificación del producto
    Orthopedic Devices
  • Descripción del producto
    VANGUARD TOTAL KNEE SYSTEM - DCM - PS PLUS TIBIAL;ARCOMXL RINGLOC LINER;MAXIM KNEE SYSTEM-STEMMED TIBIAL TRAY COMPONENT;TOTAL KNEE SYSTEM - ANTERIOR STABILIZED BEARINGS;RINGLOC BIPOLAR ACETABULAR COMPONENT;MAXIM KNEE SYSTEM-PRIMARY TIBIAL TRAY;HYBRID GLEN
  • Manufacturer
    ZIMMER BIOMET CANADA INC.
  • 1 Event
    • Retiro De Equipo (Recall) de VANGUARD TOTAL KNEE SYSTEM - DCM - PS PLUS TIBIAL BEARINGS
UniVise Inserter
  • Modelo / Serial
    Reference Number 48590100 Lots B40155, B34446, B34447 and B41171.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.
  • Manufacturer
    Stryker Spine
  • 1 Event
    • Retiro De Equipo (Recall) de UniVise Inserter
Universal Notch Preparation Guide, Size #3
  • Modelo / Serial
    All lots manufactured since 1998. Catalog Number 7650-3363. Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430; authorized representative in Europe: Stryker France ZAC Satolas Green Pusignan; Cedex, France.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Products were distributed worldwide.
  • Descripción del producto
    Universal Notch Preparation Guide, Size #3; || Non Sterile; || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430; || authorized representative in Europe: || Stryker France ZAC Satolas Green Pusignan; || Cedex, France.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Universal Notch Preparation Guide, Size #3
Universal Cables
  • Modelo / Serial
  • Clasificación del producto
    Orthopedic Devices
  • Descripción del producto
    Medical electronics / Electromedical devices
  • Manufacturer
    ConMed Linvatec
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Universal Cables
Universal Cable
  • Modelo / Serial
  • Clasificación del producto
    Orthopedic Devices
  • Descripción del producto
    Medical electronics / Electromedical devices
  • Manufacturer
    ConMed Linvatec
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Universal Cable
Ultra Power Burs, Sterile, Single-Use.
  • Modelo / Serial
    All product with an expiration date between August 2004 and August 2009.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed to 492 customers throughout the United States, and 301 customers internationally.
  • Descripción del producto
    Ultra Power Burs, Sterile, Single-Use.
  • Manufacturer
    Linvatec Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Ultra Power Burs, Sterile, Single-Use.
TX 8 Driver
  • Modelo / Serial
    Lot #145B08
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- including states of CO, OR, and TX.
  • Descripción del producto
    Normed TX 8 Driver, Non-Cannulated (used with the Ascension Total Foot System); Catalog #503004268; distributed by Ascension Orthopedics, Inc., Austin, TX 78754. || Orthopedic manual surgical screwdriver.
  • Manufacturer
    Ascension Orthopedics, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de TX 8 Driver
Turon Glenoid Reamer
  • Modelo / Serial
    Catalog number, Lot Number S-200956, 535U1000 S-200957, 536U1000 S-200958, 537U1000
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    OH, VA
  • Descripción del producto
    MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: || REF S-200956 - 5mm PIN, SIZE 46 || REF S-200957 - 5mm PIN, SIZE 50 || REF S-200958 - 5mm PIN, SIZE 58
  • Manufacturer
    Encore Medical, Lp
  • 1 Event
    • Retiro De Equipo (Recall) de Turon Glenoid Reamer
Trigger Finger Blades
  • Modelo / Serial
    Model number 1052; Lots M674180, MAKL170, M674200
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution including the states of: AZ, MI, NE, NV, and TX.
  • Descripción del producto
    Endotrig Trigger Release Sterile Micro Hook Blade || Product Usage: || The blade is intended to release A-1 pulley in endoscopic trigger release procedures.
  • Manufacturer
    Instratek, Incorporated
  • 1 Event
    • Retiro De Equipo (Recall) de Trigger Finger Blades
TRIGEN SURESHOT Distal Targeting System
  • Modelo / Serial
    All serial numbers prior to and including ACA5
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NM, OH, PA, TN, TX, AND WA and the countries of Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland, Turkey, and the UK.
  • Descripción del producto
    smith & nephew TRIGEN SURESHOT Distal Targeting System, Trauma Interface, V2.0.2, Trauma Launcher V1.01.1 || Product is intended to be an intraoperative image-guided localization system. It is a computer-assisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation.
  • Manufacturer
    Smith & Nephew Inc
  • 1 Event
    • Retiro De Equipo (Recall) de TRIGEN SURESHOT Distal Targeting System
Trident Insert Impactor
  • Modelo / Serial
    Catalog Number: 2111-0000
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    The product has been distributed the Howmedica branches and sales reps, hospitals, and International Howmedica distributors located in Sweden, China, France, Netherlands, Germany, Spain, Australia, Japan, New Zealand, Switzerland, Portugal, England, Chile, and Brazil.
  • Descripción del producto
    Trident Insert Impactor
  • Manufacturer
    Stryker Howmedica Osteonics
  • 1 Event
    • Retiro De Equipo (Recall) de Trident Insert Impactor
Triathlon Navigation Tibial Alignment Handle
  • Modelo / Serial
    Catalog No.: 6541-2-807 N1A0l, N1K07 N1K14 N1N64 N1W04 N2A11 N2H10 N2L16 N2N04 N2V25 N2V26 N3E08 N3H12 N3H29 N3K02 N3K56 N3L13 N3S33 N3S39 N3T78 N3V21 N3W18 N3W29 N3W47 NYC02 NYC10 NYL09 NZC10 NZH09 NZL08 NZM01 NZS08 NZV09 customer Parts associated with cat. no. 6540-2-807 I-K2072AH00 - Triathlon Tibial Align. Handle with Secondary Lock I-K2336AH00 - Tibial Alignment Handle with Lock I-K2021TA00 - Triathlon Alignment Handle with Navigation Post I-K2059KT00 - Triathlon Tibia Alignment Handle I-K3254TA00 - Triathlon Tibial Alignment Handle with Lock I-K3251AH00 - Triathlon Tibial Alignment Handle for Sizes 1-3 I-K3113TH00 - Triathlon Tibial Alignment Handles (Augment) I-K2980 - Triathlon Tibia Alignment Handle I-K2954AH00 - Triathlon Tibia Alignment Handle I-K2916TA00 - Triathlon Tibial Alignment Handle I-K2797AH00 - Tibial Alignment Handle with no swivel Catalog No. 6541-2-8089 N1K14 N1N63 N1W08 N3K50 N3M43 N3T61 N3V56 N4E36
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Asia Pacific, Canada, Europe, Middle East and Africa (EMEA), and Japan
  • Descripción del producto
    Tibial Alignment Handle || Triathlon Instruments || CAT #: 6541-2-807 || Nav Tibial Alignment Handle Triathlon Instruments || CAT #; 6541-2-808 || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430 || The tibial alignment handles Cat# 6451-2-807 and 6541-2-808 are part of the Triathlon Knee Instruments set. The alignment handle is used after the tibial resection portion of a total knee arthroplasty procedure. The alignment handle helps holding and orienting the tibial template and trial, which are used to estimate the size and assess the orientation of the final implant. The implant will provide the new bearing surface of the knee, replacing the damaged joint.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Triathlon Navigation Tibial Alignment Handle
Transforaminal Lumbar Interbody Fusion (TLIF) pack
  • Modelo / Serial
    Lot numbers 140312147 140613795 140714523
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to Florida, New York and Puerto Rico..
  • Descripción del producto
    Transforaminal Lumbar Interbody Fusion (TLIF) pack, Catalog # 900-2918 || Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Transforaminal Lumbar Interbody Fusion (TLIF) pack
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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.