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
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Product | CinchLock Flex Knotless Anchor with Inserter;
Model number CAT02643;
Orthopedic:
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/ Manufacturer |
Stryker Corporation 5900 Optical Ct San Jose CA 95138-1400
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For Additional Information Contact | Michael Hilldoerfer 408-754-2664 |
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.
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = MBI
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