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.
This recall has been terminated (originally issued August 8, 2013).
- Company
- Spinefrontier, Inc.
- Recall Initiated
- August 29, 2012
- Posted
- August 8, 2013
- Terminated
- October 18, 2013
- Recall Number
- Z-1932-2013
- Quantity
- 11
- Firm Location
- Beverly, MA
- Official Source
- View on FDA website ↗
Reason for Recall
During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.
Distribution
US Distribution including the states of MA, NV and TX.
Lot / Code Info
Lot Numbers: 1335201A, 1446101A
Root Cause
Process design
Action Taken
On August 29, 2011, The Supply Chain Team was notified of the recall via email. They were informed that all handles are being pulled from the field. This resulted in the return of all T-Handles to SpineFrontier. Further questions please call (978) 232-3990.
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