FDA Device

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.

Hazard

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.

What You Should Do

Remedy

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.

Products

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 supp
Brand
Orthopedic Systems Inc
UPC
Product Number 5979-300, listing 878.4950.

Units Affected

8 units distributed.