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Recall Observatory FDA recall evidence

Device 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.

Z-1635-2016

April 12, 2016

Class II

Product summary

Firm
Stryker Corporation
Event
Event 73846
Status
Terminated
Classification
Class II
Quantity
3100 total devices, both models
Official record key
device-enforcement:Z-1635-2016

Official wording

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.

Code information: Model number: CAT02643; Serial numbers: 15122202, 16011301,16020802

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.