Events

Recall of ANCHORLOK

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
    59998
  • Event Risk Class
    Class 2
  • Event Number
    Z-0064-2012
  • Event Initiated Date
    2011-09-20
  • Event Date Posted
    2011-10-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104209
  • 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
    The product is labeled with an expiration date without adequate justification.
  • Action
    The firm, Wright Medical Technology, Inc., sent an "URGENT: PRODUCT RECALL NOTIFICATION" letter dated September 20, 2011 to all affected consignees. The letters identified the products, the problem, and the actions to be taken. The letter instructed consignees to identify affected inventory. If recalled products are located consignees are instructed to contact customer service at 1-800-238-7117, for specific instructions on how to return the recalled products. The letter asked that this communication be forward to any associated sites if the recalled products were further distributed. Consignees are to complete and return the enclosed notification form by fax to 901-867-7401 or by email to: cathy.park@wmt.com. For questions regarding this recall contact 901-867-4324.

Device

ANCHORLOK
  • Model / Serial
    Lot Numbers: 01516050108, 02916090204, 02916090209, 03016100308, 03716070319, 03916090306, 03916090313, 04116110428, 04416040428, 04516050419, 04916090403, 05116110513, 05516050505, 05516050517, 06016100604, 06416040622, 06616060607, 06616060630, 06716070601, 06716070622, 06916090626, 07416040723, 07616060721, 07816080702, 07816080702, 07816080710, 08016100728, 08016100820, 08416040828, 08616060801, 08716070808, 08816080805, 08916080906, 09916090902, 10716071002, 10816081030, 10916091013, 11316031114, 11616061112, 11716071104, 12316031210, 12816081204, 12916091228
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and countries of: Argentina, Canada, Denmark, France, Great Britain, Ireland, Japan, and Spain.
  • Product Description
    ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 3.5mm, 2 SUTURE, REF 5100-0014, 1 each, STERILE R, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002 || Product Usage: The instrument is used as a soft tissue anchor
  • 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