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FDA Medical Device Recalls

View 10000 FDA Medical Device Recalls on BEUDAMED, the Better Database on Medical Devices. This searchable listing aggregates recall notices issued by the U.S. Food and Drug Administration for devices removed, corrected, or returned due to safety, labeling, or performance concerns. Each record summarizes the recall reason, affected models and lots, recall class, and recommended actions for patients and providers.

Searchable filters help stakeholders identify affected manufacturers, device models, and recall classes (Class I–III) and review timelines and remediation steps. Healthcare providers and purchasers can use these records to verify whether inventory is affected and to implement recommended corrections, returns, or patient notifications.

Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, right, 13 MM height, for use with baseplate size 3,4 or 5, sterile, Zimmer, Warsaw, IN; REF 00-5428-023-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.

FDA Recall
Terminated ·Zimmer Inc.·Product code JWH·October 8, 2009

Stryker Medical Stair-PRO Stair Chair with wheels and a track system, patient transport device, Model 6252.

FDA Recall
Terminated ·Stryker Medical Div. of Stryker Corporation·Product code FPP·September 2, 2009

Zimmer Natural Nail System, Connecting Knob, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-000-11. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.

FDA Recall
Terminated ·Zimmer Inc.·Product code HSB·July 1, 2009

Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, tall, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-05. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.

FDA Recall
Terminated ·Zimmer Inc.·Product code HSB·July 1, 2009

Zimmer Natural Nail System, Antegrade Femoral Recon Module, small, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-008-08. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.

FDA Recall
Terminated ·Zimmer Inc.·Product code HSB·July 1, 2009

Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 40MM, spinal implant component

FDA Recall
Terminated ·Stryker Spine·Product code KWQ·October 2, 2009

Intelligent 60mm Articulating Endoscopic Linear Cutter, product code i60; Intelligent 60mm Articulating Endoscopic Linear Cutter Extra Long, product code i60XXL; Intelligent 45mm Articulating Endoscopic Linear Cutter, product code i45; Intelligent 45mm Articulating Endoscopic Linear Cutter, Vascular, product code i45V.

FDA Recall
Terminated ·Surgical Devices/Covidien·Product code GDW·September 23, 2009

IntelliVue Clinical Information Portfolio (ICIP) Critical Care Release D, Version D.02. Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage.

FDA Recall
Terminated ·Philips Healthcare Inc.·Product code DXJ·October 21, 2009

Intelligent 60mm Straight Endoscopic Linear Cutter, product code i60S; Intelligent 60mm Straight Endoscopic Linear Cutter Reconditioned, product code i60SRC.

FDA Recall
Terminated ·Surgical Devices/Covidien·Product code GDW·September 23, 2009

Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 58MM, spinal implant component

FDA Recall
Terminated ·Stryker Spine·Product code KWQ·October 2, 2009