Zimmer Affixus Antegrade Femoral Nailing System recalled for fracture risk
What this means
Zimmer, Inc. is recalling specific lots of Affixus Antegrade Femoral Nails (model 815509400, 9 mm, 400 mm length) used in thigh bone surgery. Some implants may have a manufacturing defect that makes the shaft undersized, which could cause the nail to fracture over time.
- If you had thigh bone surgery with an Affixus nail, contact your surgeon or orthopedic doctor immediately with your implant lot number
- Ask your doctor to verify whether your implant is from one of the affected lots (66717555, 66884565, or 67379212)
- Follow your doctor's guidance on whether monitoring, imaging, or replacement surgery 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-0971-2026More 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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