FDAFDA · Food and drugs·Recall number Z-1366-2022
Wright EVOLVE TRIAD Plate Cutter, REF 49510120
Published July 20, 2022 · Recall initiated: June 14, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Wright Medical Technology, Inc.
- Distributor
- Nationwide and PR, and Australia, Canada, Chile, Colombia, Hong Kong, Puerto Rico
- Lot
- Lot codes: 955401, 1168853, 1349302, 1956936, 2486857
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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