Monterey AL Implant Inserter; 22mm; Catalog 48019140.
FDA Recall #Z-1491-2025 — Class II — February 28, 2025
Product Description
Monterey AL Implant Inserter; 22mm; Catalog 48019140.
Reason for Recall
Potential for the gold unlock button to separate from the inserter.
Recalling Firm
Stryker Spine — Allendale, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
44 units (41 US, 3 OUS)
Distribution
Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada.
Code Information
Catalog 48019140; UDI-DI: 07613327501124; Lot Number: 231640;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated