Zimmer Affixus Antegrade Femoral Nailing System recalled for fracture risk
What this means
Zimmer, Inc. is recalling specific Affixus Antegrade Femoral Nailing System implants (model 815609380, 9 mm, 380 mm length, left side) because they may have a manufacturing defect that makes the shaft undersized. This defect could cause the implant to break over time, potentially requiring additional surgery.
- If you received this implant, contact your surgeon immediately with your implant information
- Do not attempt to remove or replace the implant yourself—only a surgeon should do this
- Ask your surgeon whether your specific implant lot is affected and if monitoring or replacement is needed
- Keep your implant documentation and lot number available when you contact your healthcare provider
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-0978-2026More 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
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.