Recall Z-1932-2013
SpineFrontier, Inc. · initiated August 29, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot Numbers: 1335201A, 1446101A
Reason for recall
During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.
FDA-determined 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.
Details
- Recall number
- Z-1932-2013
- Initiated
- August 29, 2012
- Posted by FDA
- August 8, 2013
- Terminated
- October 18, 2013
- Product code
- MDM – Instrument, Manual, Surgical, General Use
- Quantity
- 11
- Distribution
- US Distribution including the states of MA, NV and TX.
- Recalling firm
- SpineFrontier, Inc., Beverly, MA