Device product
Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.
Z-1488-2025
Product summary
- Firm
- Stryker Spine
- Event
- Event 96349
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 64 units (60 US, 4 OUS)
- Official record key
device-enforcement:Z-1488-2025
Official wording
Reason: Potential for the gold unlock button to separate from the inserter.
Code information: Catalog 48019100; UDI-DI: 07613327456462; Lot Number: 231634;
Distribution pattern: Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada.
Derived failure modes
-
Unknown
Potential for the gold unlock button to separate from the inserter.