Events

Recall of Device Recall TI ANCHOR 2.5MM W / 20 SUTURE, GFORCE (R) SUTURE ANCHOR,

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Wright Medical Technology Inc.

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
    57854
  • Event Risk Class
    Class 2
  • Event Number
    Z-1525-2011
  • Event Initiated Date
    2011-01-11
  • Event Date Posted
    2011-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97587
  • 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
    Driver may break during use.
  • Action
    Wright Medical Technology Inc initiated their recall of the product by telephone to their distributors on January 11, 2011. The firm followed with letters sent on February 1, 2011, to distributors, hospital administrators, and surgeons. Distributors were asked to immediately complete the attached response form, confirming receipt of the notice, and return a copy to Wright Medical by fax to 901-867-4788. For questions they were instructed to call 800-874-5630. For questions regarding this recall call 901-867-4788.

Device

Device Recall TI ANCHOR 2.5MM W / 20 SUTURE, GFORCE (R) SUTURE ANCHOR,
  • Model / Serial
    Lot Numbers: 060WM037095, 060WM037107, 060WM037108, 070WM037121, 070MW037122, 070WM037130, 070MW037139
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including FL, NC, OH, IL, IN
  • Product Description
    TI ANCHOR 2.5MM W / 2-0 SUTURE, G-FORCE (R) SUTURE ANCHOR, Tissue Anchor, REF 86TA-2520, Rx ONLY, Sterile EO, Wright, Arlington, TN USA || Used in the repair of tendons and ligaments
  • Manufacturer
    Wright Medical Technology Inc

Manufacturer

Wright Medical Technology Inc
  • Manufacturer Address
    Wright Medical Technology Inc, 5677 Airline Rd, Arlington TN 38002-9501
  • Manufacturer Parent Company (2017)
    Wright Medical Group NV
  • Source
    USFDA