PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: May 18, 2016 Initiated: April 12, 2016 #Z-1634-2016

Product Description

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.

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

Details

Recalling Firm
Stryker Corporation
Units Affected
3100 total device, both model numbers.
Distribution
Distributed US (nationwide) and in Australia, Switzerland, Netherlands, Spain and Sweden.
Location
San Jose, CA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Stryker Corporation. Units affected: 3100 total device, both model numbers..
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 18, 2016. Severity: Moderate. Recall number: Z-1634-2016.

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