Class II

Medical Device Recall: Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.

Stryker Spine · February 28, 2025

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.

States Affected

CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT

Quantity Affected

64 units (60 US, 4 OUS)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1488-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.