FDA Medical Device Recalls (openFDA)
Stryker Spine: Monterey AL Implant Inserter; 22mm; Catalog 48019140.
- Recall number
- Z-1491-2025
- Recalling firm
- Stryker Spine
- Product
- Monterey AL Implant Inserter; 22mm; Catalog 48019140.
- Status
- Open, Classified
- Initiated
- 2025-02-28
- Posted
- 2025-03-31
- Terminated
- not on file
- 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 the Product Affected Table are in scope of this recall. Inserters from other lots should not be returned. 3. Use the Business Reply Form (BRF) to reconcile any affected product. Complete the Business Reply Form even if there is no affected product identified. 4. Within five (5) business days of receipt of this notification, return the enclosed Business Reply Form by email to Spine-RegulatoryActions@Stryker.com or complete the eForm to confirm receipt of this notification/document quantity of product on hand. 5. If you have further distributed this product to other organizations, provide contact details on the BRF so that Stryker can inform the recipients appropriately. 6. If you desire additional training associated with these instructions, please contact our Regulatory Compliance team by calling 201.749.8090 or by email at Spine-RegulatoryActions@Stryker.com. 7. Under 21 CFR 803, manufacturers are required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Stryker informed of any adverse events associated with this product by using Stryker s online reporting site: https://www.stryker.com/productexperience. Additionally, adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/s
- Quantity
- 44 units (41 US, 3 OUS)
- Distribution
- Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada.
- Lot, serial or model codes
- Catalog 48019140; UDI-DI: 07613327501124; Lot Number: 231640;
- 510(k) numbers
- ["K201585"]
- PMA numbers
- not on file
- Product code
- OVD
- Firm FEI
- 3004024955
- Firm city
- Allendale
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28