Zimmer recalls Affixus Antegrade Femoral Nails with possible undersized diameter that could cause fracture, leading to pain, surgery, or tissue damage. Affected units include specific model and lot numbers.
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.
Zimmer is recalling Affixus Antegrade Femoral Nails that may have undersized shaft diameter, which could cause the implant to fracture. This fracture risk might lead to pain, surgery, or tissue damage requiring medical intervention.
The implants may have a smaller diameter than intended along their length, causing repeated stress that can lead to fractures. If a fracture occurs, it might cause pain, failed healing, or require additional surgery to repair tissue damage.
Patients who received the recalled Affixus Antegrade Femoral Nails during surgery are affected. Those with the specific model and lot numbers listed in the recall are at risk.
Check the model number on the implant (815609380) and lot number (66717604 or 66892903). The product was sold as part of Zimmer's Affixus Antegrade Femoral Nailing System.
Identify the model number (815609380) and lot number (66717604 or 66892903) on the implant.
The implants may have undersized shaft diameter, which could lead to fracture and cause pain, failed healing, or surgery.
Check the model number and lot number on the implant. If it matches the recalled units, contact Zimmer for further instructions.
The recall states that fractures could cause pain, non-union, or tissue damage requiring surgery, but it does not specify that the implant causes death or serious injury in normal use.
We’ve drafted a message you can send Zimmer to request your refund or repair — edit it as you like.
Subject: Recall Z-0978-2026 — Zimmer Zimmer Hello, I own a Zimmer that is covered by recall Z-0978-2026 from Zimmer. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
