Zimmer Gmbh
Zimmer Gmbh 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-2529-2026, 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 biomet spine, zimmer trabecular metal technology, zimmer spine, zimmer medical (malaysia), zimmer biomet (thailand) co, zimmer india private limited, zimmer biomet taiwan co, zimmer biomet korea
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2529-2026 | Class II | Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number | May 20, 2026 |
| Z-2531-2026 | Class II | Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476 | 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-2528-2026 | Class II | Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Numbe | 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-0970-2026 | 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-0974-2026 | 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-0982-2026 | 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-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-0972-2026 | 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-0977-2026 | 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-0969-2026 | 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 |
|---|---|---|
| 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 |