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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Product Detail

Product Description Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). Product Usage: The connector assemblies allow for rod components to be connected side-to-side, or end-to-end and eliminate the need of rebuilding the entire system with a longer rod in order to include the new vertebral levels.
Recall Number Z-0896-2013
Classification Class II
Code Info Catalog Numbers: 52-6800 & 52-6700; All Lot Numbers
Product Distributed Qty 565 total (287 PN 52-6800 and 278 PN 52- 6700)
Reason For Recall There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connector Assembly (p/n 52-6800) & Axial Rod Connector (p/n 52-6700) may crack during final tightening. Orthofix Inc received six (6) customer complaints related to set screw cracking between November 15, 2010 and December 2012.

Event Detail

Event Id 64265
Product Type Devices
Status Ongoing
Recalling Firm Orthofix, Inc
City Lewisville
State TX
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-01
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwidewide Distribution - USA Nationwide including Puerto Rico and the countries of: Australia, Lebanon, Germany, Spain, Sweden and Israel.