FDA Device

Optima Spinal System and Spinal Hook System, set screw component.

Hazard

Threads on a set screw, as a component of a spinal fixation system, may break off during use.

What You Should Do

Remedy

Consignee was notified by letter on 08/10/2004.

Products

Optima Spinal System and Spinal Hook System, set screw component.
Brand
U & I America
UPC
Part number SP3020 (revision 6), Lot # 04D033.

Units Affected

200 set screws