FDA Medical devices recall ·
Monterey AL Implant Inserter recall
- Recall number
- Z-1488-2025
- Date
- (initiated February 28, 2025)
- Company / brand
- Stryker Spine
59 State Rt 17 S, Allendale, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 64 units (60 US, 4 OUS)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.
Why was it recalled?
Potential for the gold unlock button to separate from the inserter.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog 48019100; UDI-DI: 07613327456462; Lot Number: 231634;
Distribution
Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada.
States: California Colorado Florida Georgia Illinois Massachusetts Nebraska New Hampshire New York Oklahoma Pennsylvania Texas Utah
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1488-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.