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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Event Detail

Event ID 64991
Product Type Devices
Status Completed
Recalling Firm SpineFrontier, Inc.
City Beverly
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2008-05-10
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide distribution: US (nationwide) to states of: CO, MA, and TX; and country of: Jamaica.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices. Lot number: 20856 Class II During two separate occasions an impactor plate on the handle broke off while being struck by a mallet. 10 Z-1482-2013