Recall Z-0976-2026 ยท HSB Rod, Fixation, Intramedullary And Accessories
Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Left, Trochanteric Nail Component: N/A
| Date | Dec 22, 2025 (initiated Dec 2, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process design |
| Action | 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 recommen |
| Quantity | 24 |
| Distribution | US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K241651 | Affixus Tibial and Antegrade Femoral Nailing System Zimmer, Inc., Sep 26, 2024 |