Recall Z-1366-2022— Wright Medical Technology, Inc.
Class II · Ongoing
Class II FDA medical device recall by Wright Medical Technology, Inc., initiated 2022-06-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Wright EVOLVE TRIAD Plate Cutter, REF 49510120. Reason: 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.
- Recalling firm
- Wright Medical Technology, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-06-14
- Firm location
- Memphis, TN, United States
Product description
Wright EVOLVE TRIAD Plate Cutter, REF 49510120
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.