Zimmer Affixus Antegrade Femoral Nailing System recalled for fracture risk
What this means
Zimmer, Inc. is recalling specific lots of Affixus Antegrade Femoral Nails (9 mm, 420 mm length, left side) used in thighbone fracture surgery. Some implants may have a manufacturing defect that weakens the nail shaft, increasing the risk of the implant breaking inside the leg.
- If you had thighbone fracture surgery with an Affixus nail, contact your surgeon or hospital immediately with your surgery date and location.
- Ask your surgeon to check your surgical records to see if you received one of the recalled nail lots (66717606 or 66892905).
- Do not delay—a broken implant may require additional surgery.
- Watch for new or worsening leg pain, instability, or difficulty walking, and report these symptoms to 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-0980-2026More 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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