Summary
The FDA issued a Class II for Monterey AL Implant Inserter; 18/20mm; Catalog 48019130. by Stryker Spine. Reason: Potential for the gold unlock button to separate from the inserter..
Details
Source
Device Recall
External ID
Z-1490-2025
Action Date
2025-04-09
Status
Ongoing
Category
device
Product Description
Monterey AL Implant Inserter; 18/20mm; Catalog 48019130.
Lot/Code Info: Catalog 48019130; UDI-DI: 07613327501049; Lot Number: 231639;
Quantity Affected: 46 units (44 US, 2 OUS)
Reason for Recall
Potential for the gold unlock button to separate from the inserter.
Distribution
Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-28
Company
Allendale, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 182 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stryker Spine has 13 FDA actions in our database, including 8 recalls and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stryker Spine) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker Spine have FDA actions?
Stryker Spine has 13 FDA actions in our database, including 8 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1490-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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