Events

Recall of CinchLock Flex Knotless Anchor with Inserter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73846
  • Event Risk Class
    Class 2
  • Event Number
    Z-1635-2016
  • Event Initiated Date
    2016-04-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145099
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Fastener, fixation, nondegradable, soft tissue - Product Code MBI
  • Reason
    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.
  • Action
    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.

Device

CinchLock Flex Knotless Anchor with Inserter
  • Model / Serial
    Model number: CAT02643; Serial numbers: 15122202, 16011301,16020802
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed US (nationwide) and in Australia, Switzerland, Netherlands, Spain and Sweden.
  • Product Description
    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.
  • Manufacturer
    Stryker Corporation

Manufacturer

Stryker Corporation
  • Manufacturer Address
    Stryker Corporation, 5900 Optical Ct, San Jose CA 95138-1400
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA