Stryker Corporation recalls CinchLock Flex Knotless Anchor with Inserter; Model number CAT02643; Orthopedic: The Pivot CinchLock SS Knotless Anchor…

Recall date

April 12, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1635-2016

FDA classification

Class II

Brand / firm

Stryker Corporation

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.