CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; 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.
This recall has been terminated (originally issued April 12, 2016).
- Company
- Stryker Corporation
- Recall Initiated
- April 12, 2016
- Terminated
- December 12, 2016
- Recall Number
- Z-1634-2016
- Quantity
- 3100 total device, both model numbers.
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
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 s of an internal wire breaking upon deployment of the anchor.
Distribution
Distributed US (nationwide) and in Australia, Switzerland, Netherlands, Spain and Sweden.
Lot / Code Info
Model number: CAT02462 Serial numbers: 15120801, 15121401, 16010402, 16011901, 16012501.
Root Cause
Device Design
Action Taken
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.