Events

Recall of Device Recall Contender Postop Knee Brace Full Foam

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

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
    72727
  • Event Risk Class
    Class 2
  • Event Number
    Z-0580-2016
  • Event Initiated Date
    2015-11-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142116
  • 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
    Joint, knee, external brace - Product Code ITQ
  • Reason
    Knee brace could fail to maintain the locked position and a loss of balance or undesired flexion/extension may occur at the affected knee joint,.
  • Action
    Corflex notified customers on November 12, 2015, initially via phone. On December 9, 2015, a follow-up letter dated December 8, 2015, was issued via email with read receipt. Customers have been instructed to return all product to Corflexs Manchester, NH manufacturing facility. This removal includes product that is new, in use and no longer in service. Customers have been provided instructions on how to contact our Customer Service department to initiate the return process and generate a Returns Material Authorization. UPS Call Tags are also being issued to facilitate the return of braces at no cost to the customer. Contact Corflex at service@corflex.com or via phone at (800) 426-7353, Monday through Friday, 8:00 am to 4:30 pm, EST

Device

Device Recall Contender Postop Knee Brace Full Foam
  • Model / Serial
    (1) all braces that begin with a Revision Code of AN, AP, AQ, AR, AS, AT, AU are to be returned to Corflex immediately for review; (2) all braces with a Revision Code beginning with AM and that comply with the date range: Braces manufactured between September 1, 2015 and November 6, 2015
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Canada , Taiwan , Singapore , and England.
  • Product Description
    CONTENDER POST-OP-KNEE BRACE FULL FOAM || Model: 75-7550-000 || Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.
  • Manufacturer
    Corflex

Manufacturer

Corflex
  • Manufacturer Address
    Corflex, 669 E Ind Park Dr, Manchester NH 03109-5625
  • Manufacturer Parent Company (2017)
    Corflex Inc.
  • Source
    USFDA