Public recall detail

Evolve Triad Plate Cutter

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Recall Safety notice
Quick summary

Quick summary: Evolve Triad Plate Cutter.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Evolve Triad Plate Cutter.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandWright Medical Technology Inc.
ProductEvolve Triad Plate Cutter
IssueMedical devices - Sterility
Recall classType II
IdentificationRA-64258

Affected products

ProductEvolve Triad Plate Cutter
Lot2486857 1349302 1956936 955401 1168853
Model49510120
Serial number2486857 1349302 1956936 955401 1168853
DescriptionEvolve Triad Plate Cutter

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Orthopaedics
CompaniesWright Medical Technology Inc. 1023 Cherry Road, Memphis, Tennessee, United States, 38117
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-64258
Background{}
CompaniesWright Medical Technology Inc. 1023 Cherry Road, Memphis, Tennessee, United States, 38117
AudiencesHealthcare
Source updated2022-06-13

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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