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.
FDA Recall Z-1932-2013 · Posted 2013-08-08
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Recalling FirmSpineFrontier, Inc.
Recall StatusTerminated
Product CodeMDM
Date Initiated2012-08-29
Date Terminated2013-10-18
Product Quantity11
Reason for Recall
During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.
Firm 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.
Root Cause
Process design
Distribution Pattern
US Distribution including the states of MA, NV and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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