Zimmer Biomet Recalls
875 recalls on record · January 20, 2016 to December 30, 2020 · Medical Devices
Recalls by year
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17
18
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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.
July 24, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509
Hazard: Lack of an adequate sterilization validation.
July 10, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Express Disposable Instruments are used to facil
Hazard: There is a potential for weak seals of the sterile packaging.
July 10, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls DVR Crosslock ePAK Depth Gauge, Model Number 212000003 Product Usage: These DVR Express Disposable Instruments are u
Hazard: There is a potential for weak seals of the sterile packaging.
July 10, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposable Instruments are
Hazard: There is a potential for weak seals of the sterile packaging.
June 26, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item Number: 0024-LD
Hazard: Incorrect part description contained on an additional label placed on the packaging: A 14mm length part was incorrectly labeled as being a 12mm length screw
June 12, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421930 System Domed Lateral F
Hazard: Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
June 12, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421060 Phase 3 Femoral Drill G
Hazard: Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
June 12, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420324Phase 3 Femoral Drill Gui
Hazard: Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
June 12, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420323 Phase 3 Femoral Drill G
Hazard: Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
June 12, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420322 Phase 3 Femoral Drill Gu
Hazard: Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
June 12, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420321 Phase 3 Femoral Drill Gu
Hazard: Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
June 12, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobi
Hazard: Etching on the tulip head incorrectly states "24MM" instead of the correct "28MM" marking.
May 15, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls T7 Driver Solid AO (Part Number 110018541) Product Usage: The Biomet Headless Compression Screws and Twist-Off Screw
Hazard: There is a potential of fracture, bending or shearing of the driver.
May 15, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls T7 Driver Cannulated AO (Part Number 110018531) Product Usage: The Biomet Headless Compression Screws and Twist-Off
Hazard: There is a potential of fracture, bending or shearing of the driver.
April 10, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Titanium, Accessory to total hip implant Item
Hazard: Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.
April 10, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip implant Item
Hazard: Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.
April 10, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical proc
Hazard: Lack of an adequate sterilization validation
March 13, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet C
Hazard: The product was potentially being packaged without a taper adapter.
March 6, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766
Hazard: Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.
March 6, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764
Hazard: Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.
January 23, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003 Product Usage: Intended to carry implants
Hazard: There is a potential for silicone shedding during cleaning and sterilization.
January 23, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants a
Hazard: There is a potential for silicone shedding during cleaning and sterilization.
January 16, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product Usage: Usage: The system is intended for
Hazard: One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 029980) contains 18mm locking screws
January 16, 2019Medical DevicesFDA
Zimmer Biomet, Inc. recalls Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Product Usage: The system is intended for stabi
Hazard: One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 029980) contains 18mm locking screws
December 26, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation Spindle 17
Hazard: Correction to update the surgical technique for the Compress System. To make users aware of the changes that were made only to the selection criteria section on page 42 regarding which array to use in the placement of the anti-rotation pins.
December 26, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls NexGen¿ Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Number: 00599003523 N
Hazard: Screw is missing from the package
December 19, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Comprehensive Mini Stem, Item No. 113631:
Hazard: Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. The associated risk of this product issue is a potential extension of surgery <30 minutes if a replacement is readily available.
December 19, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394
Hazard: Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. The associated risk of this product issue is a potential extension of surgery <30 minutes if a replacement is readily available.
December 12, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant Item number: 178562 Pro
Hazard: Potential metal burrs in the holes of the device preventing the appropriate drill and transverse pins from being inserted
December 12, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-
Hazard: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility