Zimmer Affixus Antegrade Femoral Nailing System recalled for undersized shaft risking fracture
What this means
Zimmer Affixus Antegrade Femoral Nails (9 mm, 400 mm length, left side) may have a smaller-than-intended diameter along the shaft. This could cause the implant to weaken and break over time, leading to pain, improper bone healing, or the need for additional surgery.
- If you received this implant, contact your surgeon or orthopedic doctor right away with the lot number from your medical records
- Do not delay—discuss your implant status and any symptoms you're experiencing
- Your doctor will advise whether monitoring, imaging, or replacement is needed
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-0979-2026More Zimmer Biomet recalls
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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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