FDA-Device2025-04-09Class II
Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.
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
64 units (60 US, 4 OUS)
Manufactured in
59 State Rt 17 S, Allendale, NJ, United States
Products
Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1488-2025Don't want to check this manually?
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