FDA-Device2013-08-14Class II
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 patien
SpineFrontier, Inc.
Hazard
During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.
Sold states
US Distribution including the states of MA, NV and TX.
Affected count
11
Manufactured in
500 Cummings Ctr Ste 3500, N/A, Beverly, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1932-2013Don't want to check this manually?
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