Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197

FDA device recall Z-1328-2025 · posted 2025-03-12 · Open, Classified

Recall details

Recalling firm

Stryker Corporation

Reason for recall

Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.

Action taken

On January 29, 2025, Stryker issued a "Urgent Medical Device Recall " notification to affected consignees via: certified mail. Stryker ask consignees to take the following actions: Inform individuals within your organization who need to be aware of this device recall. 2. Check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your account. Response is required by January 30, 2026. 3. If affected product is found, quarantine and discontinue use of the recalled devices. Please complete the Business Reply Form (page 3) of this notice and return devices back to Stryker Endoscopy. a. Please call Customer Service at (800)624-4422 or email EndoCustomerSupport@stryker.com to arrange for product return and issuance of credit or replacement (upon availability). 4. Inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients appropriately. 5. If no product is found, complete the acknowledgement form and return it back to Stryker via email to EndoRecall@stryker.com.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

MBI

Quantity affected

9521 units

Distribution

Worldwide - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, I

Date initiated

2025-01-29

Date posted

2025-03-12

Location

San Jose, CA

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