FDA Enforcement
Class II
Ongoing
Monterey AL Implant Inserter; 18/20mm; Catalog 48019130.
Recall: Z-1490-2025
·
Reported April 9, 2025
Enforcement
- Recall Number
- Z-1490-2025
- Event ID
- 96349
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Stryker Spine
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- April 9, 2025
- Initiation Date
- February 28, 2025
- Classification Date
- March 31, 2025
- Address
- 59 State Rt 17 S, Allendale, NJ, 07401-1614, United States
Description
Monterey AL Implant Inserter; 18/20mm; Catalog 48019130.
Reason
Potential for the gold unlock button to separate from the inserter.
Code Info
Catalog 48019130; UDI-DI: 07613327501049; Lot Number: 231639;
Distribution
Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada.
Quantity
46 units (44 US, 2 OUS)