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U.S. Department of Health and Human Services

Class 2 Device Recall CinchLock Flex Knotless Anchor with Inserter

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  Class 2 Device Recall CinchLock Flex Knotless Anchor with Inserter see related information
Date Initiated by Firm April 12, 2016
Create Date May 10, 2016
Recall Status1 Terminated 3 on December 12, 2016
Recall Number Z-1635-2016
Recall Event ID 73846
510(K)Number K151314  
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
Product CinchLock Flex Knotless Anchor with Inserter;
Model number CAT02643;

The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used for repair of hip, shoulder, foot and ankle, elbow, wrist and hand and knee.
Code Information Model number: CAT02643; Serial numbers: 15122202, 16011301,16020802
Recalling Firm/
Stryker Corporation
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information Contact Michael Hilldoerfer
Manufacturer Reason
for Recall
Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of an internal wire breaking upon deployment of the anchor.
FDA Determined
Cause 2
Device Design
Action Urgent Medical Device Recalls letters were sent on April 12, 2016 to US customers by certified mail. Stryker International distribution sites will be notified by e-mail. Letters describe the reason for recall with the affected part and lot numbers. Any recalled product should be segregated and returned to Stryker.
Quantity in Commerce 3100 total devices, both models
Distribution Distributed US (nationwide) and in Australia, Switzerland, Netherlands, Spain and Sweden.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MBI and Original Applicant = Pivot Medical