FDA Device recall Z-1489-2025
Monterey AL Implant Inserter
- FDA Device
- Class II
- ongoing
- Published 2025-04-09
On 2025-04-09 the FDA classified a Class II recall of Monterey AL Implant Inserter by Stryker Spine, citing potential for the gold unlock button to separate from the inserter.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1489-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-28 |
| Published | 2025-04-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Stryker Spine |
| Distribution | CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT |
Product
Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.
Reason
Potential for the gold unlock button to separate from the inserter.
Identifiers
| code_info | Catalog 48019120; UDI-DI: 07613327500998; Lot Number: 231638; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1489-2025%22
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