Zimmer Affixus Antegrade Femoral Nails recalled for fracture risk
What this means
Zimmer, Inc. recalled 22 Affixus Antegrade Femoral Nails (9 mm, 340 mm length, right-sided) because the implants may have an undersized shaft diameter that could cause the nail to break inside the leg over time. If the implant fractures, it may cause pain, improper bone healing, tissue damage, or require additional surgery.
- If you received this implant, contact your surgeon immediately with lot number 66717552 or 66884562
- Your surgeon will determine if you need imaging or follow-up care
- Do not delay—discuss your implant and any leg pain or discomfort with your doctor
The agency's original wording
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-0968-2026More Zimmer Biomet recalls
- FDA-Device2026-07-01Zimmer Off-Axis Comprehensive Shoulder System Reamer Guide recalled for plastic breakage during surgery
- FDA-Device2026-07-01Zimmer Off-Axis Comprehensive Shoulder System reamer guide recalled for breakage risk
- 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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