FDA-Device2025-04-09Class II

Monterey AL Implant Inserter; 18/20mm; Catalog 48019130.

Stryker Spine
Hazard

Potential for the gold unlock button to separate from the inserter.

Sold states
Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada.
Affected count
46 units (44 US, 2 OUS)
Manufactured in
59 State Rt 17 S, Allendale, NJ, United States
Products
Monterey AL Implant Inserter; 18/20mm; Catalog 48019130.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1490-2025

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