Biomet, Inc.
Biomet, Inc. appears in FDA public data with 274 recalls, 444 510(k) clearances, 10 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-0212-2026, Class II) was initiated on September 23, 2025. Its most recent 510(k) clearance was granted on July 1, 2026.
Summary
- Total Recalls
- 274
- 510(k) Clearances
- 444
- Inspections
- 10
- Compliance Actions
- 2
Known Names
biomet, biomet 3i, biomet manufacturing, biomet microfixation, biomet spine, biomet spine and bone healing technologies
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0212-2026 | Class II | BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation Sys | September 23, 2025 |
| Z-2619-2025 | Class II | Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080 | September 9, 2025 |
| Z-0477-2025 | Class II | JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357 | October 21, 2024 |
| Z-2179-2024 | Class II | RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty It | May 17, 2024 |
| Z-1607-2024 | Class II | Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product | March 13, 2024 |
| Z-0569-2024 | Class II | Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01 | November 2, 2023 |
| Z-0570-2024 | Class II | Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02 | November 2, 2023 |
| Z-0383-2024 | Class II | Compress Device Short Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthr | October 9, 2023 |
| Z-0385-2024 | Class II | Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsuccessful osteotomy, arthr | October 9, 2023 |
| Z-0387-2024 | Class II | Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthr | October 9, 2023 |
| Z-0381-2024 | Class II | Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful osteotomy, arthrode | October 9, 2023 |
| Z-0371-2024 | Class II | Compress Device Segmental Anchor Plug, 12 MM -For Correction of revision of unsuccessful osteotomy, | October 9, 2023 |
| Z-0376-2024 | Class II | Compress Device Segmental Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, a | October 9, 2023 |
| Z-0374-2024 | Class II | Compress Device Segmental Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, a | October 9, 2023 |
| Z-0375-2024 | Class II | Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, a | October 9, 2023 |
| Z-0373-2024 | Class II | Compress Device Segmental Anchor Plug, 16 MM-For Correction of revision of unsuccessful osteotomy, a | October 9, 2023 |
| Z-0378-2024 | Class II | Compress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessful osteotomy, arthrodes | October 9, 2023 |
| Z-0370-2024 | Class II | Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, a | October 9, 2023 |
| Z-0386-2024 | Class II | Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthr | October 9, 2023 |
| Z-0380-2024 | Class II | Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthr | October 9, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K253434 | OSSTM Orthopedic Salvage System | July 1, 2026 |
| K251270 | Taperloc® Complete Hip Stem | May 19, 2026 |
| K241014 | Biomet Kirschner Wires (K-Wires) | May 22, 2024 |
| K222760 | StageOne Select Hip Cement Spacer Molds | December 28, 2022 |
| K221968 | StageOne Shoulder Cement Spacer Molds | September 15, 2022 |
| K213287 | StageOne Knee Cement Spacer Molds | September 2, 2022 |
| K212431 | Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve | February 7, 2022 |
| K212435 | Comprehensive Humeral Fracture Positioning Sleeves | December 10, 2021 |
| K210192 | A.L.P.S. Clavicle Plating System | February 19, 2021 |
| K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless C | November 10, 2020 |
| K193546 | Distal Centralizers | September 25, 2020 |
| K193373 | Comprehensive® Reverse Shoulder | April 15, 2020 |
| K193402 | ALLthread PEEK Suture Anchor | March 5, 2020 |
| K193451 | Titanium Interference Screws | February 24, 2020 |
| K193533 | WIN Flexible Nail System | February 20, 2020 |
| K192942 | ALLthread Titanium Suture Anchor | January 16, 2020 |
| K193092 | TunneLoc Tibial Fixation Device | January 2, 2020 |
| K191459 | JuggerStitch Meniscal Repair Device | September 13, 2019 |
| K190035 | Biomet Headless Compression and Twist-Off Screws | February 7, 2019 |
| K183553 | Compress and Mini Compress Anti-Rotation Spindles | January 22, 2019 |