Zimmer Affixus Antegrade Femoral Nails recalled for fracture risk
Check if you received Zimmer femoral nail implant
Zimmer, Inc. recalled certain Affixus 9 mm femoral nails (model 815509360, length 360 mm) because the shaft may be undersized and prone to breaking. If the implant fractures, it could cause pain, improper bone healing, tissue damage, or require additional surgery.
- Contact your orthopedic surgeon if you had a femoral nail implant placed, especially between August and September 2023.
- Ask your surgeon to check your implant lot number against the recalled batches (66717553 or 66884563).
- Do not delay—implant fracture may require urgent surgical repair.
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-0969-2026More Zimmer Biomet recalls
- FDA-Device2026-07-01Zimmer Off-Axis Comprehensive Shoulder System Reamer Guide recalled for plastic breakage during surgery
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- 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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