Health product recall

Evolve Triad Plate Cutter

Last updated

Summary

Product
Evolve Triad Plate Cutter
Issue
Medical devices - Sterility Issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Evolve Triad Plate Cutter

2486857
1349302
1956936
955401
1168853

49510120

Issue

Stryker has identified a nonconformance relating to the Evolve Triad Plate Cutter provided in the Evolve Triad Instrument Kit (4951kit1). Specifically, 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 (IFU150824). While the surgical technique does not require use of the plate cutter, it is provided in the instrument kit so the coronoid plate can be trimmed when needed.

Recall start date: June 3, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Orthopaedics
Companies

Wright Medical Technology Inc.

1023 Cherry Road, Memphis, Tennessee, United States, 38117

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64258

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