Zimmer Affixus Antegrade Femoral Nailing System recalled for potential implant fracture
What this means
Zimmer, Inc. is recalling certain Affixus 9 mm femoral nails (Model 815509300, Lot 66717550) used in hip and thigh bone fracture surgery. Some implants may have a thinner-than-expected diameter that could cause the nail to fracture over time, potentially requiring additional surgery.
- If you received this implant, contact your surgeon or orthopedic clinic immediately with your medical records
- Do not delay—your doctor needs to verify if you have an affected implant
- Your surgeon may recommend monitoring, imaging, or replacement depending on your situation
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-0983-2026More 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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