Z-1366-2022 Class II Ongoing
FDA device recall Z-1366-2022 was initiated by Wright Medical Technology, Inc. on Jun 14, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 231.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 20, 2022
- Initiation Date
- Jun 14, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 231
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
Distribution Pattern
Nationwide and PR, and Australia, Canada, Chile, Colombia, Hong Kong, Puerto Rico
Code Information
Lot codes: 955401, 1168853, 1349302, 1956936, 2486857
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1366-2022
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026