Events

Recall of Device Recall DYNASTY ACLASS POLY LINER

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
    56131
  • Event Risk Class
    Class 3
  • Event Number
    Z-2212-2010
  • Event Initiated Date
    2010-06-07
  • Event Date Posted
    2010-08-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92717
  • 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
    Prothesis, hip, semi-contrained (metal cemented acetaular component) - Product Code JDL
  • Reason
    The inner and outer product packaging was missing the following information: shelf life, translations, manufacturing date, ce marking and also listed the incorrect sterilization method.
  • Action
    On 06/28/2010, Wright Medical Technology sent a letter to consignees. Consignees were instructed to examine their inventory for recalled product and return it to the firm. Consignees should contact customer service at 800-238-7117 for return instructions and replacement inventory. Questions concerning the recall should be directed to Debby Daurer at 800-874-5630.

Device

Device Recall DYNASTY ACLASS POLY LINER
  • Model / Serial
    Lot number: 0501136375
  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    USA distirbution only, in states of WI, WV, IN, IA, and GA
  • Product Description
    DYNASTY¿ A-CLASS¿ POLY LINER, REF DLXP-LD36, 1 EACH, Rx ONLY, STERILE EO, GROUP D, I.D. 36 mm, LIP 15o, LINER STD, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002. Product is used in total hip arthroplasty.
  • Manufacturer
    Wright Medical Technology Inc

Manufacturer

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