Public recall detail

Monterey AL AL Implant Inserter

2025-03-10

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Recall Safety notice
Quick summary

Quick summary: Monterey AL AL Implant Inserter. Date: 2025-03-10.

Recommended action

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

Recall details

Quick summary: Monterey AL AL Implant Inserter. Date: 2025-03-10.

Official details

Affected product details

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

BrandStryker Spine
ProductMonterey AL AL Implant Inserter
IssueMedical devices - Performance
Recall classType II
IdentificationRA-77086

Affected products

ProductMonterey AL AL Implant Inserter
Lot231639 231638 231640 231634
Model48019140 48019130 48019100 48019120
Serial number231639 231638 231640 231634
DescriptionMonterey AL AL Implant Inserter

Issue

For the lots in scope of this assessment, there has been a trend of reports from the field that found there was the potential for the gold unlock button to separate from the inserter. Investigation determined that this is due to potential tolerance interference within the design that can lead to the pin not being flush, causing weld penetration to not meet specification and the gold unlock button to separate from the inserter. Recall Start Date: February 27, 2025

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Orthopaedics
CompaniesStryker Spine 2 Pearl Court, Allendale, New Jersey, United States, 07401
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-77086
Background{}
CompaniesStryker Spine 2 Pearl Court, Allendale, New Jersey, United States, 07401
AudiencesHealthcare
Source updated2025-03-10

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

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