Recall Z-1489-2025 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Stryker Spine
Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.
| Date | Mar 31, 2025 (initiated Feb 28, 2025) |
| Status | Open, Classified |
| Reason | Potential for the gold unlock button to separate from the inserter. |
| Root cause | Device Design |
| Action | On February 28, 2025 URGENT MEDICAL DEVICE RECALL letters to inventory contacts. Actions needed 1. Immediately review the Product Recall Notification. Please forward this information to all sales representatives and operations teams within your Branch/Agency. Maintain awareness of this communication internally until all required actions have been completed within your facility. 2. Immediately check your internal inventory to locate the product listed on the attached Business Reply Form and remove them from their point of use. Note: Only Monterey AL Inserters with the lot number specified in th |
| Quantity | 56 units (53 US, 3 OUS) |
| Distribution | Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201585 | Monterey AL Interbody System Stryker Corporation, Aug 10, 2020 |