Zimmer Affixus Antegrade Femoral Nails recalled for potential fatigue fracture risk
Contact your surgeon about Zimmer Affixus femoral nail
Zimmer, Inc. is recalling certain Affixus Antegrade Femoral Nails (9 mm, 320 mm length, right-sided) because the implant shaft may be undersized. This manufacturing defect could cause the nail to break over time, which may lead to pain, bone healing problems, or the need for additional surgery.
- If you have received this implant, contact your surgeon or orthopedic surgeon immediately
- Do not delay medical care or remove the implant without consulting your doctor
- Ask your surgeon whether your implant is affected (check lot numbers 66717551 or 66884561)
- Follow your surgeon's guidance on monitoring or replacement options
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0967-2026More Zimmer Biomet recalls
- FDA-Device2026-07-01Zimmer Off-Axis Comprehensive Shoulder System Reamer Guide recalled for plastic breakage during surgery
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- FDA-Device2026-07-01Zimmer Off-Axis Alliance Glenoid Reamer Guide recalled for breakage during surgery
- FDA-Device2026-07-01Zimmer Persona Revision Femoral Distal Augment recalled for wrong component in package
- FDA-Device2026-07-01Zimmer Off-Axis Alliance Glenoid Reamer Guide recalled for plastic breakage risk during surgery
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