Z-1489-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 9, 2025
- Initiation Date
- February 28, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 56 units (53 US, 3 OUS)
Product Description
Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.
Reason for Recall
Potential for the gold unlock button to separate from the inserter.
Distribution Pattern
Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada.
Code Information
Catalog 48019120; UDI-DI: 07613327500998; Lot Number: 231638;