Medical device recalls Moderate risk

Stryker Spine recalls Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.

Recall date
February 28, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1489-2025
FDA classification
Class II
Brand / firm
Stryker Spine
Sold / distributed
Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.

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