Class 2 Device Recall inchLock Flex Knotless Anchor with Inserter and Suture

• Date Initiated by Firm: January 29, 2025
• Date Posted: March 12, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1328-2025
• Recall Event ID: 96281
• 510(K)Number: K151314
• Product Classification: Fastener, fixation, nondegradable, soft tissue - Product Code MBI
• Product: Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
• Code Information: UDI:07613327123661/ Lot #s: 23342AE2 24190AE2 23345AE2 24200AE2 24004AE2 24201AE2 24008AE2 24204AE2 24009AE2 24205AE2 24010AE2 24206AE2 24032AE2 24214AE2 24033AE2 24215AE2 24036AE2 24221AE2 24050AE2 24222AE2 24061AE2 24226AE2 24064AE2 24233AE2 24065AE2 24235AE2 24066AE2 24240AE2 24087AE2 24248AE2 24093AE2 24249AE2 24094AE2 24250AE2 24127AE2 24256AE2 24128AE2 24257AE2 24135AE2 24258AE2 24136AE2 24260AE2 24137AE2 24276AE2 24143AE2 24277AE2 24144AE2 24278AE2 24159AE2 24283AE2 24160AE2 24284AE2 24162AE2 24285AE2 24169AE2 24292AE2 24170AE2 24306AE2 24184AE2 24309AE2 24185AE2 24311AE2 24186AE2 24312AE2
• Recalling Firm/ Manufacturer: Stryker Corporation; 5900 Optical Ct; San Jose CA 95138-1400
• For Additional Information Contact: Endo Customer Support; 800-624-4422
• Manufacturer Reason for Recall: Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.
• FDA Determined Cause: Under Investigation by firm
• Action: 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.
• Quantity in Commerce: 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, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Argentina, Colombia, Netherlands, Spain, Mexico, Australia, United Kingdom, Brazil.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MBI