Recall Z-1634-2016 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Stryker Corporation
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.
| 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 s 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 device, both model numbers. |
| 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
| K131769 | CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM Pivot Medical, Inc., Oct 7, 2013 |