Z-2645-2023Class II

Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462

Name: Z-2645-2023 Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462
Creator: Stryker Corporation
Published: 2023-08-23
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2023-08-23 / Open, Classified

FDA source

Stryker Corporation began a recall of Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462 on 2023-08-23. FDA classified it as Class II and gives the reason as "Expired Product distributed". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2645-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-23
Posted: 2023-09-28
Recalling firm: Stryker Corp.
Product: Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: Expired Product distributed
FDA root cause: Unknown/Undetermined by firm
Action: On August 23, 2023, Stryker issued an "Urgent Medical Device Recall Notification" to affected consignees via . Stryker asked consignees to take the following actions: Actions needed: 1. Inform individuals within your organization who need to be aware of this device recall. 2. Check all inventory to determine if any devices from the affected product list are located at your facility. Response is required by September 30, 2023. 3. If affected product is found, quarantine and discontinue use of the recalled devices. Please complete the response form on Appendix A of this notice and return devices back to Stryker Endoscopy. 4. If no product is found, complete acknowledgement form and return it back to Stryker.
Quantity in commerce: 96 units
Distribution: US Nationwide distribution in the states of NY, NC, GA, TN, KY, IL, UT, AZ, NM, CA.
Product codes and lots: Lot # 19175AE2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2645-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2645-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-04	2023-09-28

Product code MBI

K131769Class IICinchlock Knotless Suture Anchor, Nanotack Suture Anchor 1.4MmPivot Medical, Inc. / cleared 2013-10-07

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)