Z-1491-2025Class II

Monterey AL Implant Inserter; 22mm; Catalog 48019140

Name: Z-1491-2025 Monterey AL Implant Inserter; 22mm; Catalog 48019140
Creator: Stryker Spine
Published: 2025-02-28
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2025-02-28 / Open, Classified / root cause: design

FDA source

Stryker Spine began a recall of Monterey AL Implant Inserter; 22mm; Catalog 48019140 on 2025-02-28. FDA classified it as Class II and gives the reason as "Potential for the gold unlock button to separate from the inserter". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1491-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-28
Posted: 2025-03-31
Recalling firm: Howmedica Osteonics Corp
Product: Monterey AL Implant Inserter; 22mm; Catalog 48019140.
Product code: OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Reason for recall: Potential for the gold unlock button to separate from the inserter.
Root cause tag: design
FDA 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 [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
Quantity in commerce: 44 units (41 US, 3 OUS)
Distribution: Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada.
Product codes and lots: Catalog 48019140; UDI-DI: 07613327501124; Lot Number: 231640;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1491-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1488-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-03-31
Z-1489-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-03-31
Z-1490-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-03-31
Z-1491-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-03-31

Product code OVD

K201585Class IIMonterey AL Interbody SystemStryker Corporation / cleared 2020-08-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)