Public recall detail

Aequalis® Flex Revive® Assembly Screw

2023-06-21

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Recall Safety notice
Quick summary

Quick summary: Aequalis® Flex Revive® Assembly Screw. Date: 2023-06-21.

Recommended action

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

Recall details

Quick summary: Aequalis® Flex Revive® Assembly Screw. Date: 2023-06-21.

Official details

Affected product details

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

BrandTornier Inc.
ProductAequalis® Flex Revive® Assembly Screw
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-73861

Affected products

ProductAequalis® Flex Revive® Assembly Screw
LotAZ1322077005
ModelARS655101
Serial numberAZ1322077005
DescriptionAequalis® Flex Revive® Assembly Screw

Issue

Stryker has identified a nonconformance in a specific lot of Aequalis® Flex Revive® Assembly Screws. Specifically, a comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis® Flex Revive® Assembly Screws 0mm standard (ARS655101) but it was a Aequalis® Flex Revive® Assembly Screw 0mm short (ARS655118) & vice versa. Recall start date : June 7, 2023

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Healthcare Industry
CategoryHealth products - Medical devices - Orthopaedics
CompaniesTornier Inc. 10801 Nesbitt Avenue South, Bloomington, Minnesota, United States, 55437
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-73861
Background{}
CompaniesTornier Inc. 10801 Nesbitt Avenue South, Bloomington, Minnesota, United States, 55437
AudiencesGeneral public Healthcare Industry
Source updated2023-06-21

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

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