Zimmer Affixus Antegrade Femoral Nailing System recalled for fracture risk
Check if your femoral nail is affected
Zimmer has recalled certain Affixus 9 mm femoral nails (320 mm length, left side) because the metal shaft may be undersized. This defect could cause the implant to crack over time, potentially leading to pain, improper bone healing, or the need for additional surgery.
- Contact your orthopedic surgeon or hospital if you received this implant
- Ask your doctor to verify your implant model and lot number against the recall list
- Keep the lot numbers and UDI codes handy: 66717601 and 66892900
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-0975-2026More Zimmer, Inc. recalls
- 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 plastic breakage risk during surgery
- FDA-Device2026-07-01Zimmer Persona Revision Femoral Distal Augment recalled for wrong component in package
- FDA-Device2026-07-01Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
- FDA-Device2026-07-01Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242
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