Zimmer Affixus Antegrade Femoral Nailing System recalled for undersized shaft fracture risk
Contact your surgeon about Zimmer Affixus femoral nail
Zimmer, Inc. recalled specific lots of Affixus Antegrade Femoral Nails (9 mm, 340 mm, Left) because the implant shaft may be undersized. This could cause the nail to break over time after surgical implantation, potentially leading to pain, improper bone healing, or the need for additional surgery.
- If you received this implant between the affected lot numbers, contact your orthopedic surgeon or hospital immediately
- Ask your surgeon whether your implant is part of this recall by providing lot number 66717602 or 66892901
- Do not delay—discuss next steps with your surgeon, including possible 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-0976-2026More Zimmer, Inc. recalls
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- FDA-Device2026-07-01Zimmer Off-Axis Comprehensive Shoulder System reamer guide recalled for breakage risk
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