Zimmer Biomet recalls specific lots of Gentle Threads Interference Screw (Model 90560: 326960) due to potential infection from overexposure during EtO sterilization. Affected users should contact the company for details.
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 905608) because overexposure during EtO sterilization may cause infection. This recall affects surgeons and medical facilities using the device for soft tissue procedures.
Overexposure during EtO sterilization can compromise the sterile barrier, potentially leading to infection. This risk occurs if the device is used after being sterilized in an overexposed cycle.
Surgeons and medical facilities using the specific lot number 326960 of the Gentle Threads Interference Screw for ankle/foot or knee procedures are most at risk.
Check for the model number 905608 on the device and the lot number 326960. The device is used for soft tissue reattachment procedures in the ankle, foot, or knee.
Reach out to Zimmer Biomet directly to confirm if your device is affected and get instructions for next steps.
The device may pose an infection risk if overexposed during EtO sterilization, so affected users should contact Zimmer Biomet for details.
Contact Zimmer Biomet to determine if your specific lot number is affected and follow their instructions.
Look for the model number 905608 and lot number 326960 on the device. Contact Zimmer Biomet if you have these details.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1738-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1738-2018 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.
