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Terminated

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.

FDA Recall Z-1635-2016 · Posted None

Recalling FirmStryker Corporation
Recall StatusTerminated
Product CodeMBI
Date Initiated2016-04-12
Date Terminated2016-12-12
Product Quantity3100 total devices, both models

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Distributed US (nationwide) and in Australia, Switzerland, Netherlands, Spain and Sweden.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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