FDA-Device2025-12-31Class IIPROCESSING DEFECT

Zimmer Affixus Antegrade Femoral Nail (9mm, 280mm) recalled for fracture risk

OTHERNationwide distribution

Contact your surgeon about Zimmer Affixus femoral nail

Zimmer, Inc. is recalling a specific batch of Affixus Antegrade Femoral Nails (9 mm, 280 mm length, left Piriformis) used in thigh bone fracture repair. The affected implants may have a manufacturing defect that weakens the nail shaft and could cause it to break inside the leg. If this happens, patients may experience pain, improper bone healing, or need another surgery.

If you received this implant between April 2035 and April 2035, contact your surgeon immediately with your implant lot number (67066287) or UDI code
Your surgeon can determine if your implant is affected and whether monitoring or replacement is needed
Do not attempt to remove or adjust the implant yourself

Hazard

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.

Sold states

US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.

Affected count

Manufactured in

1800 W Center St, N/A, Warsaw, IN, United States

Products

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815809280 Software Version: N/A Product Description: Affixus 9 mm, Length 280 mm, Left, Priformis Nail Component: N/A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0982-2026

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