Device product

Wright EVOLVE TRIAD Plate Cutter, REF 49510120

Z-1366-2022

June 14, 2022

Class II

Product summary

Firm: Wright Medical Technology, Inc.
Event: Event 90399
Status: Ongoing
Classification: Class II
Quantity: 231
Official record key: device-enforcement:Z-1366-2022

Official wording

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

Code information: Lot codes: 955401, 1168853, 1349302, 1956936, 2486857

Distribution pattern: Nationwide and PR, and Australia, Canada, Chile, Colombia, Hong Kong, Puerto Rico

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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