Stryker Corporation recalls Stryker CinchLock Flex Knotless Anchor with Inserter and Suture

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-1328-2025
• FDA 510(k) clearance · K151314The device's official FDA premarket clearance record
• FDA device classification · MBIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3040The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Stryker CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.