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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Product Detail

Product Description 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.
Recall Number Z-1932-2013
Classification Class II
Code Info Lot Numbers: 1335201A, 1446101A
Product Distributed Qty 11
Reason For Recall During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.

Event Detail

Event Id 64993
Product Type Devices
Status Ongoing
Recalling Firm SpineFrontier, Inc.
City Beverly
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-29
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern US Distribution including the states of MA, NV and TX.