Zimmer Biomet recalls specific lots of Gentle Threads Interference Screw (Model 90561: 326980, 371540) due to potential infection from overexposure during EtO sterilization.
Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Zimmer Biomet is recalling specific lots of Gentle Threads Interference Screws (Model 905615) for soft tissue reattachment procedures. The recall is because some units were overexposed during EtO sterilization, which could lead to infection if the sterile barrier is compromised.
Overexposure during EtO sterilization can compromise the sterile barrier, potentially leading to infection. This risk occurs if the device is used after the sterilization process without proper quality checks.
Surgical patients and healthcare providers using the specific lots of Gentle Threads Interference Screws (Model 905615) for ankle/foot or knee procedures. Those most at risk are patients receiving surgery with the recalled lots.
Check the lot numbers on the device: 326980 or 371540. The product is used for soft tissue reattachment procedures in the ankle/foot and knee.
Look for lot numbers 326980 or 371540 on the device packaging.
Model No. 905615 for Gentle Threads Interference Screws.
Overexposure during EtO sterilization may lead to infection from loss of sterile barrier.
Check the lot numbers: 326980 or 371540 on the device packaging.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1739-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1739-2018 from Zimmer Biomet. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.