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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Product Detail

Product Description 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.
Recall Number Z-1482-2013
Classification Class II
Code Info Lot number: 20856
Product Distributed Qty 10
Reason For Recall During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.

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 Other
Distribution Pattern Worldwide distribution: US (nationwide) to states of: CO, MA, and TX; and country of: Jamaica.