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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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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
Distribution Pattern US Distribution including the states of MA, NV and TX.

Product Detail

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