Zimmer Biomet Recalls
875 recalls on record · January 20, 2016 to December 30, 2020 · Medical Devices
Recalls by year
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20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 7, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls The 2nd Assist Knee Positioner
Hazard: Zimmer Biomet is conducting a medical device recall for the 2nd Assistant Knee Positioner due to the potential for the sterile packaging barrier to be breached during distribution.
March 7, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls 979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.
Hazard: Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail.
March 7, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls 14-442000S Antegrade Femoral Nail Instrument Kit, orthopedic instrument
Hazard: Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail.
March 7, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa, Model#14-442093 Antegrade Femoral Connecting Bolt.
Hazard: Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail.
March 7, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: a. VERSYS 6 INCH BEADED FC 19X160MM STD BODY
Hazard: The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier.
March 7, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (Item No. 00585001201); b. Size B-RT (I
Hazard: The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier.
February 28, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 Product Usage: For us
Hazard: Knee implant components (tibial bearings) are labeled with the incorrect size.
February 28, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in to
Hazard: Knee implant components (tibial bearings) are labeled with the incorrect size.
February 28, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and o
Hazard: Robot arm being sent to the wrong position
February 28, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and ori
Hazard: Robot arm being sent to the wrong position
February 21, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For use in Total Knee A
Hazard: The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.
February 21, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Ar
Hazard: The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.
February 21, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal o
Hazard: The affected products are labeled and etched as F-44 mm liners; however, the physical products could potentially be E-42 mm liners.
February 21, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut
Hazard: Cut resistant surgical glove liners lack sterility assurance.
February 21, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to faci
Hazard: Potential for the Persona Partial Knee Impactor Pad to fracture.
February 14, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length, Item Number 47-2490-098-01 Product Us
Hazard: The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging configuration. As a result, the products packaged in the previous packaging configuration are being removed.
February 14, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length, Item Number 47-2490-098-00 Product Us
Hazard: The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging configuration. As a result, the products packaged in the previous packaging configuration are being removed.
February 14, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length, Item Number 47-2255-008-00 Product Usage: The Ball Tip and
Hazard: The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging configuration. As a result, the products packaged in the previous packaging configuration are being removed.
February 14, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 0
Hazard: The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging configuration. As a result, the products packaged in the previous packaging configuration are being removed.
February 14, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-22
Hazard: The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging configuration. As a result, the products packaged in the previous packaging configuration are being removed.
February 14, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE
Hazard: A raw material anomaly was discovered in four lots of raw material and has the potential to be on or below the surface of the device components which can increase the risk of instrument fracture
February 7, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Affixus Hip Fracture Nail, RH 130 DEG 9MM X 440MM
Hazard: During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
February 7, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Affixus Hip Fracture Nail, RH 130 DEG 9MM X 420MM
Hazard: During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
February 7, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Affixus Hip Fracture Nail, RH 130 DEG 9MM X 400MM
Hazard: During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
February 7, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Affixus Hip Fracture Nail, RH 130 DEG 9MM X 380MM
Hazard: During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
February 7, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Affixus Hip Fracture Nail, RH 130 DEG 9MM X 360MM
Hazard: During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
February 7, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Affixus Hip Fracture Nail, RH 130 DEG 9MM X 340MM
Hazard: During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
February 7, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Affixus Hip Fracture Nail, RH 130 DEG 9MM X 320MM
Hazard: During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
February 7, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Affixus Hip Fracture Nail, RH 130 DEG 9MM X 300MM
Hazard: During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
February 7, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Affixus Hip Fracture Nail, RH 130 DEG 9MM X 260MM
Hazard: During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.