Wright Medical recalls specific models of EVOLVE TRIAD Plate Cutters that may not meet sterilization standards when double-wrapped for steam sterilization, posing infection risks during medical procedures.
The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped configuration according to the Option 1 Steam Sterilization parameters detailed in instructions for use
Wright Medical is recalling certain EVOLVE TRIAD Plate Cutters that could fail to meet sterilization requirements when used in double-wrapped configurations. This risk could lead to infections during medical procedures if the device is not properly sterilized.
The plate cutter may not meet sterilization standards when double-wrapped for steam sterilization as per the manufacturer's instructions. This could result in unsterilized instruments being used in medical procedures, increasing infection risks.
Healthcare facilities using the specific lot codes of the Wright EVOLVE TRIAD Plate Cutter (REF 49510120) are affected. Staff handling surgical instruments may be at risk if the device is not sterilized correctly.
Check for the model number REF 49510120 and lot codes 955401, 1168853, 1349302, 1956936, or 2486857 on the device or packaging.
Identify the lot code on the plate cutter or packaging to confirm if it matches the recalled numbers: 955401, 1168853, 1349302, 1956936, or 2486857.
The product may not meet sterilization requirements when double-wrapped for steam sterilization, so it should not be used in this configuration without verification.
Check the lot code on the device or packaging; affected units have lot codes 955401, 1168853, 1349302, 1956936, or 2486857.
The recall does not specify a remedy, so contact Wright Medical for guidance on safe handling or disposal.
We’ve drafted a message you can send Wright Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1366-2022 — Wright Medical Wright Medical Hello, I own a Wright Medical that is covered by recall Z-1366-2022 from Wright Medical. 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.
