Zimmer Affixus Antegrade Femoral Nailing System recalled for potential implant fracture
What this means
Zimmer, Inc. is recalling specific lots of the Affixus Antegrade Femoral Nailing System (a surgical implant used to stabilize thighbone fractures) because some units may have a manufacturing defect that could cause the implant to crack or break over time. If the implant breaks, it could lead to pain, improper bone healing, or the need for additional surgery.
- If you or a family member has received this implant (model 815509420, 9 mm, 420 mm length, right side), contact your surgeon or the hospital where the procedure was performed immediately.
- Ask your doctor whether your implant is part of the recalled lot numbers (66717556 or 66884566).
- Do not attempt to remove or replace the implant yourself; follow your surgeon's guidance on next steps.
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-0972-2026More 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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