Wright Medical Technology, Inc. recalls Wright EVOLVE TRIAD Plate Cutter, REF 49510120
- Recall date
- June 14, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1366-2022
- FDA classification
- Class II
- Brand / firm
- Wright Medical Technology, Inc.
- Sold / distributed
- Nationwide and PR, and Australia, Canada, Chile, Colombia, Hong Kong, Puerto Rico
Why it was recalled
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
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Wright EVOLVE TRIAD Plate Cutter, REF 49510120
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