Recall archive / FDA device enforcement
Monterey AL Implant Inserter; 10/12mm; Catalog 48019100. — FDA record Z-1488-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 28, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.
- Reason
- Potential for the gold unlock button to separate from the inserter.
- Classification
- Class II
- Recalling firm
- Stryker Spine
- Quantity
- 64 units (60 US, 4 OUS)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1488-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Catalog 48019100; UDI-DI: 07613327456462; Lot Number: 231634; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Apr 9, 2025
- Recall initiation date
- Feb 28, 2025
- Center classification date
- Mar 31, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.