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SpineFrontier, Inc. recalls T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that h
Recalled August 14, 2013 · FDA recall Z-1932-2013 · SpineFrontier
Hazard
During an operation the strike plate of a T-Handle loosened and separated from the T-Handle. · FDA Class II
Units
11
Sold at
US Distribution including the states of MA, NV and TX.
Description
During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.
Product
T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle which is designed to be struck with a mallet. T-handles are used primarily to attach to, and operate a wide range of instruments used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients.
Manufacturer(s)
SpineFrontier, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →