Zimmer Biomet recalls specific lots of Gentle Threads Interference Screw (Model 905605) due to potential infection from overexposure during EtO sterilization. Affected lots include 326900.
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 Screw (Model 905605) used in ankle/foot and knee procedures because improper sterilization could lead to infection. This recall affects medical devices that were overexposed during the EtO sterilization process.
The device was overexposed during the EtO sterilization process, which can compromise the sterile barrier. This may lead to infection during surgery if the device is used without proper sterility.
Medical professionals using the specific lot 326900 of Gentle Threads Interference Screw for soft tissue reattachment procedures are affected. Patients who received this device during surgery may be at risk of infection.
Check the lot number on the device packaging. The affected lot is 326900. This product is used for soft tissue reattachment procedures in the ankle/foot and knee.
Look for the lot number on the device packaging; affected lots include 326900.
The device may be unsafe if it was overexposed during EtO sterilization, which could lead to infection. Affected lots are identified by the specific lot number 326900.
Check the lot number on the device packaging. If it is lot 326900, contact Zimmer Biomet for further instructions.
Patients who received the affected device during surgery may be at risk of infection. They should consult their healthcare provider for guidance.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1736-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1736-2018 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.
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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.
