Medical Device Advisories

FDA Advisory No. 2017-186 || Voluntary Recall of Cobra Distal Radius Fixator, with DVR-5258

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.

Share Us on

Submit to FacebookSubmit to Google PlusSubmit to Twitter