Recalls / —

—#203007

Product

Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462

FDA product code

MBI — Fastener, Fixation, Nondegradable, Soft Tissue

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K131769

Affected lot / code info

Lot # 19175AE2

Why it was recalled

Expired Product distributed

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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.

Recalling firm

Firm

Stryker Corporation

Address

5900 Optical Ct, San Jose, California 95138-1400

Distribution

Distribution pattern

US Nationwide distribution in the states of NY, NC, GA, TN, KY, IL, UT, AZ, NM, CA.

Timeline

Recall initiated

2023-08-23

Posted by FDA

2023-09-28

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #203007. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.