Zimmer, Inc. 2025-12-31 Health serious FDA
Health · FDA · Recall #FDA-Z-0975-2026
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… Recall
Issued December 31, 2025 · Zimmer, Inc.
In December 2025, Zimmer, Inc. recalled the Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Zimmer, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Zimmer, Inc.
- Category
- Health
- Recall date
- December 31, 2025
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.
- Recall number
- FDA-Z-0975-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Zimmer, Inc. has 5 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.