Biomet, Inc.
FDA adverse event reports naming Biomet, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: BIOMET, INC..
- Total reports
- 1,769
- Deaths
- 19
- Injuries
- 1,429
- Malfunctions
- 230
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH234
- Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)HSH171
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedJDI163
- Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedKWY111
- Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)KWA105
- Prosthesis, Hip, Hemi-, Acetabular, Cemented, MetalKWB102
- Orthopedic Manual Surgical InstrumentLXH68
- Bit, DrillHTW67
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedLPH65
- Rod, Fixation, Intramedullary And AccessoriesHSB55
Recent recalls
- 2026-08-03Open, ClassifiedUnder Investigation by firm
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm
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.
- 2026-08-03Open, ClassifiedUnder Investigation by firm
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm
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.
- 2026-08-03Open, ClassifiedUnder Investigation by firm
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm
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.
- 2026-08-03Open, ClassifiedUnder Investigation by firm
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm
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.
- 2026-08-03Open, ClassifiedUnder Investigation by firm
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm
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.
- 2025-10-17Open, ClassifiedUnder Investigation by firm
BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair
There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop
- 2025-09-23Open, ClassifiedUnder Investigation by firm
Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080
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.
- 2024-11-15Open, ClassifiedProcess control
JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357
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.
- 2024-06-25Open, ClassifiedLabeling mix-ups
RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206
41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention
- 2024-04-22Open, ClassifiedProcess change control
Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and sealed with Tyvek lid stock (outer barrier). The sealed double barrier system is placed into a paperboard carton with an IFU and label/indicator dots applied to the carton.
Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
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