Zimmer Biomet recalls specific lots of Gentle Threads Interference Screw (Model 905607) due to potential infection from overexposure during EtO sterilization. Affected lots include 326920.
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 905607) used in ankle/foot and knee procedures because overexposure during sterilization may cause infection. This recall affects surgeons and medical facilities using the specific lot number 326920.
The device was overexposed during ethylene oxide (EtO) sterilization, which can compromise the sterile barrier. This may lead to infection if the device is used without proper sterility.
Surgeons and medical facilities using the specific lot number 326920 of the Gentle Threads Interference Screw for ankle/foot and knee procedures are most at risk.
Check the lot number on the device packaging. Affected lots include 326920. The product is used in soft tissue reattachment procedures for the ankle, foot, and knee.
Look for the lot number on the device packaging; affected lots include 326920.
The recalled device is Gentle Threads Interference Screw, Model No. 905607.
Lot number 326920 is affected.
Specific lots were overexposed during EtO sterilization, which may lead to infection due to loss of sterile barrier.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1737-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-1737-2018 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.
