Class II
Medical Device Recall: Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.
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
56 units (53 US, 3 OUS)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1489-2025
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.