Zimmer Affixus Antegrade Femoral Nails recalled for potential shaft fracture
What this means
Zimmer, Inc. recalled certain Affixus Antegrade Femoral Nails (9 mm, 360 mm length, left side) because the shaft may be undersized and could fracture over time. A fractured implant could cause pain, improper bone healing, or require additional surgery.
- If you have had this implant surgically placed, contact your surgeon or orthopedic doctor immediately with your implant lot number
- Your doctor can determine if your implant is affected and whether monitoring or replacement is needed
- Keep your implant documentation and lot number (66717603, 66892902, or 67031550) available when you call
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-0977-2026More 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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