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Monterey AL recallZ-1488-2025 · Stryker Spine · initiated Feb 28, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Spine or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential for the gold unlock button to separate from the inserter.

FDA root cause category: Device Design

What the company is doing

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 [email protected] 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 [email protected]. 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

Recall details

Recall number
Z-1488-2025
Status
Open, Classified
Initiated by the company
Feb 28, 2025
Posted by the FDA
Mar 31, 2025
Recalling firm
Stryker Spine
Quantity
64 units (60 US, 4 OUS)
Product code
OVD
FDA submissions
K201585
Distribution
Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada.

Product description

Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.

Code information (models, lots, serial numbers)

Catalog 48019100; UDI-DI: 07613327456462; Lot Number: 231634;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 96349).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page