Recall Z-1635-2016 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Stryker Corporation
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.
| Date | Apr 12, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 3100 total devices, both models |
| Distribution | Distributed US (nationwide) and in Australia, Switzerland, Netherlands, Spain and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151314 | CinchLock Flex Knotless Suture Anchor Pivot Medical, Jul 23, 2015 |