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U.S. Department of Health and Human Services

Class 2 Device Recall Cinchlock SS Knotless Anchor Inserter

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 Class 2 Device Recall Cinchlock SS Knotless Anchor Insertersee related information
Date Initiated by FirmAugust 23, 2023
Date PostedSeptember 28, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2645-2023
Recall Event ID 92955
510(K)NumberK131769 
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
ProductCinchlock SS Knotless Anchor Inserter, Part Number CAT02462
Code Information Lot # 19175AE2
Recalling Firm/
Manufacturer		 Stryker Corporation
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information ContactAshley Lower
408-754-2000
Manufacturer Reason
for Recall		Expired Product distributed
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionOn 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 Commerce96 units
DistributionUS Nationwide distribution in the states of NY, NC, GA, TN, KY, IL, UT, AZ, NM, CA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MBI
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