Monterey AL AL Implant Inserter
Brand(s)
Last updated
Summary
Product
Monterey AL AL Implant Inserter
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Monterey AL AL Implant Inserter | 231639 231638 231640 231634 | 48019140 48019130 48019100 48019120 |
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Orthopaedics
Companies
Stryker Spine
2 Pearl Court, Allendale, New Jersey, United States, 07401
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77086
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