FDA (Devices) recall action 79682
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Zimmer Biomet is recalling specific lots of Gentle Threads Interference Screws because they were overexposed to ethylene oxide sterilization, which may compromise the sterile barrier.
Zimmer Biomet is recalling 54 Gentle Threads Interference Screws because overexposure to ethylene oxide sterilization may compromise the sterile barrier, increasing infection risk.
Zimmer Biomet is recalling 107 Gentle Threads interference screws because overexposure to ethylene oxide sterilization may compromise the sterile barrier, potentially leading to infection.
Zimmer Biomet is recalling 54 Gentle Threads interference screws because overexposure to ethylene oxide sterilization may compromise the sterile barrier, potentially leading to infection.
Zimmer Biomet is recalling 54 Gentle Threads interference screws because overexposure to ethylene oxide sterilization may compromise the sterile barrier, potentially leading to infection.
Zimmer Biomet is recalling 53 Gentle Threads Interference Screws because overexposure to ethylene oxide sterilization may have compromised the sterile barrier, potentially leading to infection.