Biomet, Inc.
56 E Bell Dr, WARSAW, IN, US
Registered product codes
211 product codes
Recent MDR events
85,311 on file
- PERSONA FEMORAL CR IMPACTOR PADJul 31, 2026Malfunction0001822565-2026-02720
- TIBIAL IMPACTOR BLOCKJul 31, 2026Malfunction0001822565-2026-02721
- VANGUARD PREMIER 70MM BLOCKJul 31, 2026Malfunction0001825034-2026-02226
- PERSONA FEM PS IMPACTOR PADJul 31, 2026Malfunction0001822565-2026-02724
- Comprehensive Reverse Shoulder System Humeral TrayJul 31, 2026Injury0001822565-2026-02726
- Comprehensive Reverse Shoulder System Vivacit-E Polyethylene BearingJul 31, 2026Injury0001822565-2026-02725
- Alliance Glenoid Modular Center Post ReamerJul 31, 2026Malfunction0001822565-2026-02727
- Unk GlenoidJul 31, 2026Injury0001825034-2026-02227
- Comprehensive Instrumentation 2-Prong Glenosphere Inserter/ImpactorJul 31, 2026Malfunction0001825034-2026-02228
- 36MM VIT E LINER +3MMJul 31, 2026Malfunction0001822565-2026-02719
Recalls
1,398 on file
- Open, ClassifiedAug 3, 2026
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
View FDA record ↗ - Open, ClassifiedAug 3, 2026
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
View FDA record ↗ - Open, ClassifiedAug 3, 2026
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
View FDA record ↗ - Open, ClassifiedAug 3, 2026
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
View FDA record ↗ - Open, ClassifiedAug 3, 2026
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
View FDA record ↗ - Open, ClassifiedOct 17, 2025
There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop
View FDA record ↗ - Open, ClassifiedSep 23, 2025
The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices.
View FDA record ↗ - Open, ClassifiedNov 15, 2024
Firm received complaints reporting that guides were warped when pulled out of packaging. This issue may result in extension of surgery to find another product, or may lead to adverse local tissue reaction leading to surgical intervention.
View FDA record ↗ - Open, ClassifiedJun 25, 2024
41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention
View FDA record ↗ - Open, ClassifiedApr 22, 2024
Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
View FDA record ↗
Compliance history
Matched by FEI 1825034.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Nov 9, 2023
Compliance: Devices
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.