Public recall detail

Evolve Modular Radial Head System - Cocr Stem Component

2022-08-31

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Recall Safety notice
Quick summary

Quick summary: Evolve Modular Radial Head System - Cocr Stem Component. Date: 2022-08-31.

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 Modular Radial Head System - Cocr Stem Component. Date: 2022-08-31.

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 Modular Radial Head System - Cocr Stem Component
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-64515

Affected products

ProductEvolve Modular Radial Head System - Cocr Stem Component
Lot1704255 1704691
Model496S495 496S275
Serial number1704255 1704691
DescriptionEvolve Modular Radial Head System - Cocr Stem Component

Issue

Stryker has identified a nonconformance within two specific lots of evolve proline stems. Specifically, the outer label does not match the device inside the package. the affected lot of evolve proline stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of evolve proline stem 9.5mm +4 contains a size 7.5mm +2 stem. Recall start date: August 19, 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-64515
Background{}
CompaniesWright Medical Technology Inc. 1023 Cherry Road, Memphis, Tennessee, United States, 38117
AudiencesHealthcare
Source updated2022-08-31

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

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