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Wright Medical Technology, Inc. Recall 90399

Description: Wright EVOLVE TRIAD Plate Cutter, REF 49510120

Wright Medical Technology, Inc. Recall 90399 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1366-2022
Event ID90399
Event DescriptionWright EVOLVE TRIAD Plate Cutter, REF 49510120
Product TypeDevices
DistributionNationwide and PR, and Australia, Canada, Chile, Colombia, Hong Kong, Puerto Rico
Quantity231
Recall ReasonThe 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
Device Classification20220720
Device Code InfoLot codes: 955401, 1168853, 1349302, 1956936, 2486857
Center Classification Date20220711
Recall Initiation Date20220614
Recalling FirmWright Medical Technology, Inc.
Initial Notification Letter
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