Events

Recall of Aequalis Fx2

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Tornier, 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
    75444
  • Event Risk Class
    Class 2
  • Event Number
    Z-0699-2017
  • Event Initiated Date
    2016-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150330
  • 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
    Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
  • Reason
    Tornier is conducting a recall on aequalis fx2 ( implant parts and instrument trays) due to reports of dislocations of the poly insert and the stem.
  • Action
    Wright sent an "Urgent Medical Device Recall" letter dated September 19, 2016. The letter was addressed to Healthcare Professional. The letter identified the affected product, problem and actions to be taken. It advised consignees to stop further distribution or use of product immediately. Requires consignees to notify all accounts that may be end-users, or contact Wright with your request for us to contact them. Advised consignee to complete and e-mail the attached questionnaire to FieldAction@wright.com. For questions contact the same.

Device

Aequalis Fx2
  • Model / Serial
    0924AR, 0809AR, 1110AR, 1290AR, 0811AR, 0151AR, 2447AR, 6082AQ, 5935AQ, 6373AQ, 7153AQ, 7532AQ, 9966AQ, 0018AQ, 0385AR, 0386AR, 0384AR, 3014AR, 6892AQ, 8250AQ, 6893AQ, 6924AQ, 8249AQ, 6853AQ, 6925AQ, 6962AQ, 8795AQ, 8210AQ, YKAD241, YKAD244.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution TX, CA, and MI
  • Product Description
    Aequalis Fx2 implant parts and instrument trays. || Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B. || Stem Component: Part Number: DWK111B-DWK115B, DWK121B-DWK126B, DWK131B-DWK135B. || Product Usage: || Total or partial replacement of the Gleno-humeral articulation.
  • Manufacturer
    Tornier, Inc

Manufacturer

Tornier, Inc
  • Manufacturer Address
    Tornier, Inc, 10801 Nesbitt Ave S, Bloomington MN 55437-3109
  • Manufacturer Parent Company (2017)
    Wright Medical Group NV
  • Source
    USFDA