Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:
FDA device recall Z-0972-2026 · posted 2025-12-22 · Open, Classified
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
- Action taken
- Firm began notifying customers on December 2, 2025 via Urgent Medical Device Recall letters. Distributors are to locate and quarantine affected product in their inventory. They must also return all affected product from their distributorship and from affected hospitals within their territory. Risk Managers are to assist Zimmer Biomet sales representatives in quarantining all affected product. Sales representatives will remove the product from customer facilities. Surgeons are to maintain awareness of the issue, but there are no patient-monitoring instructions related to this recall recommended beyond their existing follow-up schedules.
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- HSB
- Quantity affected
- 22
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.
- Date initiated
- 2025-12-02
- Date posted
- 2025-12-22
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Affixus Tibial and Antegrade Femoral Nailing System (K241651) | Zimmer, Inc. | 2024-09-26 |