Zimmer, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 539 (2 Class I)
- 510(k) Clearances
- 422
- Inspections
- 11
- Compliance Actions
- 0
Known Names
zimmer, zimmer spine, zimmer biomet spine, zimmer trabecular metal technology, zimmer biomet korea, zimmer biomet taiwan co
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1946-2026 | Class II | Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catal | March 30, 2026 |
| Z-0971-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails M | December 2, 2025 |
| Z-0975-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails M | December 2, 2025 |
| Z-0967-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails M | December 2, 2025 |
| Z-0977-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails M | December 2, 2025 |
| Z-0979-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails M | December 2, 2025 |
| Z-0983-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails M | December 2, 2025 |
| Z-0980-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails M | December 2, 2025 |
| Z-0968-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails M | December 2, 2025 |
| Z-0970-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails M | December 2, 2025 |
| Z-0973-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails M | December 2, 2025 |
| Z-0976-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails M | December 2, 2025 |
| Z-0969-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails M | December 2, 2025 |
| Z-0974-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails M | December 2, 2025 |
| Z-0972-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails M | December 2, 2025 |
| Z-0981-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails M | December 2, 2025 |
| Z-0978-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails M | December 2, 2025 |
| Z-0982-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails M | December 2, 2025 |
| Z-0418-2026 | Class II | Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size | September 26, 2025 |
| Z-0419-2026 | Class II | Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size | September 26, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K261683 | Augment Off-Axis Instrument System | June 16, 2026 |
| K260831 | Z1 Hip System | June 16, 2026 |
| K251840 | Zimmer® Persona® Personalized Knee System | May 28, 2026 |
| K260182 | Avenir® Müller Stem; Avenir Complete Hip System | April 27, 2026 |
| K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Compre | April 13, 2026 |
| K253566 | Affixus Retrograde Femoral Nailing System | March 12, 2026 |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) | March 9, 2026 |
| K252623 | G7® Revision Acetabular System | February 4, 2026 |
| K251098 | Identity Revision Humeral Stems | August 11, 2025 |
| K251906 | Z1 Hip System | July 18, 2025 |
| K250848 | Identity Shoulder System | July 2, 2025 |
| K243724 | Persona® Revision Knee System (Persona Revision SoluTion Femoral Components) | March 6, 2025 |
| K243907 | Affixus Tibial Nailing System - 4mm screws | February 12, 2025 |
| K241873 | OsseoFit Stemless Shoulder System | December 11, 2024 |
| K242543 | Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) | November 22, 2024 |
| K243247 | Persona the Personalized Knee System | October 29, 2024 |
| K241651 | Affixus Tibial and Antegrade Femoral Nailing System | September 26, 2024 |
| K240876 | Identity Shoulder System | June 12, 2024 |
| K240299 | Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) | April 26, 2024 |
| K230321 | Persona Personalized Knee System | March 8, 2023 |