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Recall Observatory FDA recall evidence

Device product

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.

Z-1634-2016

April 12, 2016

Class II

Product summary

Firm
Stryker Corporation
Event
Event 73846
Status
Terminated
Classification
Class II
Quantity
3100 total device, both model numbers.
Official record key
device-enforcement:Z-1634-2016

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 s of an internal wire breaking upon deployment of the anchor.

Code information: Model number: CAT02462 Serial numbers: 15120801, 15121401, 16010402, 16011901, 16012501.

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 s of an internal wire breaking upon deployment of the anchor.