Recall Z-1932-2013 ยท MDM Instrument, Manual, Surgical, General Use
SpineFrontier, Inc.
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 bo
| Date | Aug 8, 2013 (initiated Aug 29, 2012) |
| Status | Terminated |
| Reason | During an operation the strike plate of a T-Handle loosened and separated from the T-Handle. |
| Root cause | Process design |
| Action | 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. |
| Quantity | 11 |
| Distribution | US Distribution including the states of MA, NV and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092815 | S-LIF INTERVERTEBRAL BODY FUSION DEVICE Spinefrontier, Inc., Jun 30, 2010 |