FDAFDA · Food and drugs·Recall number Z-1634-2016
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.
Published May 18, 2016 · Recall initiated: April 12, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Corporation
- Distributor
- Distributed US (nationwide) and in Australia, Switzerland, Netherlands, Spain and Sweden.
- Lot
- Model number: CAT02462 Serial numbers: 15120801, 15121401, 16010402, 16011901, 16012501.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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