Recall Z-0974-2026
Zimmer, Inc. · initiated December 2, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Left, Trochanteric Nail Component: N/A
Codes / lots: Lot Code: Model No 815609300 ; UDI-DI (01)00887868144462(17)340826(10)66717600 ; Lot Number 66717600
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.
FDA-determined cause: Process design
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.
Details
- Recall number
- Z-0974-2026
- Initiated
- December 2, 2025
- Posted by FDA
- December 22, 2025
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Quantity
- 11
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.
- Recalling firm
- Zimmer, Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0967-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0968-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0969-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0970-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0971-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0972-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0973-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0975-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0976-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0977-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0978-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0979-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0980-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0981-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0982-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |
| Z-0983-2026 Class II | Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant… | 12/02/2025Open, Classified |