Zimmer Affixus Antegrade Femoral Nails recalled for fracture risk
What this means
Zimmer has recalled certain Affixus Antegrade Femoral Nails (model 815609440) used in hip fracture surgery. Some implants may have a manufacturing defect that makes them thinner than intended, which could cause the implant to crack or break over time. This could lead to pain, improper healing, or the need for additional surgery.
- If you had hip fracture surgery with a Zimmer Affixus nail, contact your surgeon immediately.
- Your surgeon can determine if your implant is affected using the lot number or product code.
- Do not delay—discuss symptoms like hip pain, ache, or difficulty with healing with your doctor right away.
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-0981-2026More 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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