Recalls / —
—#145099
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.
- FDA product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K151314
- Affected lot / code info
- Model number: CAT02643; Serial numbers: 15122202, 16011301,16020802
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.
Root cause (FDA determination)
Device Design
Action the firm took
Urgent Medical Device Recalls letters were sent on April 12, 2016 to US customers by certified mail. Stryker International distribution sites will be notified by e-mail. Letters describe the reason for recall with the affected part and lot numbers. Any recalled product should be segregated and returned to Stryker.
Recalling firm
- Firm
- Stryker Corporation
- Address
- 5900 Optical Ct, San Jose, California 95138-1400
Distribution
- Distribution pattern
- Distributed US (nationwide) and in Australia, Switzerland, Netherlands, Spain and Sweden.
Timeline
- Recall initiated
- 2016-04-12
- Terminated
- 2016-12-12
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #145099. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.