Orthopedic Systems Inc Recalls

FDA
1
Total Recalls
1
Agencies
Dec 2007
First Recall
Dec 2007
Latest Recall

Showing 1-1 of 1 recalls

FDA

Doro Products Adapter, Product number 5979-300. The adaptor system is attached to OSI''s Spinal Frame, which is an operating room tabletop that is attached to a table base. The Frame is used to support patients during spinal surgery.

Material used to manufacture accessory bracket does not meet product specification. The screw is normally composed of ''Torlon'', which is yellow. The part was made of "Tercite", which is blue.

A notification letter was sent to all 8 consignees on 02/16/2007. The firm will send service representatives to review any devices on site and replace with the proper part if needed.