FDA Device recall Z-1932-2013
T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end
- FDA Device
- Class II
- terminated
- Published 2013-08-14
On 2013-08-14 the FDA classified a Class II recall of T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end by Spinefrontier, citing during an operation the strike plate of a T-Handle loosened and separated from the T-Handle.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1932-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-29 |
| Published | 2013-08-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Spinefrontier |
| Distribution | MA, NV, TX |
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.
Reason
During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.
Identifiers
| code_info | Lot Numbers: 1335201A, 1446101A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1932-2013%22
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