Events

Safety Alert for Cobra Distal Radius Fixator

According to Food and Drug Administration Philippines, this safety alert involved a device in Philippines that was produced by Orthopaedic International, Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event Number
    2017-186
  • Event Country
    Philippines
  • Event Source
    FDAP
  • Event Source URL
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/448072-fda-advisory-no-2017-186
  • Notes / Alerts
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
  • Extra notes in the data
  • Reason
    Fda advisory no. 2017-186 voluntary recall of cobra distal radius fixator, with dvr-5258 all are hereby advised by the food and drug administration (fda) about the  cobra distal radius fixator with fda registration number dvr-5258 distributed by orthopaedic international, inc. located at #9 west road, light industry and science park 1, 4025 cabuyao, laguna : fda registration number description qc number dvr-5258 cobra distal radius fixator (aluminum) - blue 1601022 1600770 1601381 1500222 1501365 1600340 1601022 the cited medical device was voluntarily recalled by orthopaedic international, inc. because of the customer reports on potential defect/malfunction of the device. in the report, the cobra distal radius fixator is not locking, due to the detected dimensional size of the device caused of excessive deburring / buffing of the product. distributors, retailers, hospitals that have any lot of the stated medical device product are instructed to discontinue further distribution, sale and use. all consumers are likewise advised not to purchase or use the affected product lots. any suspected adverse reaction experienced or any incident of the same cases from the use of the device but not limited to the lots stated above, should be reported immediately to fda at telephone no. (02) 857-1900 loc. 8301 or email us at this email address is being protected from spambots. you need javascript enabled to view it. . dissemination of the information to all concerned is requested. attachments: fda advisory no. 2017-186.Pdf.

Device

Cobra Distal Radius Fixator

Manufacturer

Orthopaedic International, Inc