Zimmer, Inc.
Zimmer, Inc. appears in FDA public data with 545 recalls — including 2 Class I (most serious) —, 422 510(k) clearances, 11 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2531-2026, Class II) was initiated on May 20, 2026. Its most recent 510(k) clearance was granted on June 16, 2026.
Summary
- Total Recalls
- 545 (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-2531-2026 | Class II | Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476 | May 20, 2026 |
| Z-2529-2026 | Class II | Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number | May 20, 2026 |
| Z-2528-2026 | Class II | Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Numbe | May 20, 2026 |
| Z-2527-2026 | Class II | Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: | May 20, 2026 |
| Z-2530-2026 | Class II | Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444 | May 20, 2026 |
| Z-2578-2026 | Class II | Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augme | May 11, 2026 |
| Z-1946-2026 | Class II | Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catal | March 30, 2026 |
| Z-0969-2026 | 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-0979-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails M | December 2, 2025 |
| Z-0971-2026 | 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-0973-2026 | 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-0980-2026 | 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-0975-2026 | 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-0974-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails M | December 2, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K260831 | Z1 Hip System | June 16, 2026 |
| K261683 | Augment Off-Axis Instrument 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 |