Class 2 Device Recall Spine Monterey AL

• Date Initiated by Firm: February 28, 2025
• Date Posted: March 31, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1489-2025
• Recall Event ID: 96349
• 510(K)Number: K201585
• Product Classification: Intervertebral fusion device with integrated fixation, lumbar - Product Code OVD
• Product: Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.
• Code Information: Catalog 48019120; UDI-DI: 07613327500998; Lot Number: 231638
• Recalling Firm/ Manufacturer: Stryker Spine; 59 State Rt 17 S; Allendale NJ 07401-1614
• For Additional Information Contact: Kathryn Ward; 201-749-8090
• Manufacturer Reason for Recall: Potential for the gold unlock button to separate from the inserter.
• FDA Determined 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 in Commerce: 56 units (53 US, 3 OUS)
• Distribution: Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OVD