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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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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
Distribution Pattern Worldwidewide Distribution - USA Nationwide including Puerto Rico and the countries of: Australia, Lebanon, Germany, Spain, Sweden and Israel.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Catalog Numbers: 52-6800 & 52-6700; All Lot Numbers Class II 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. 565 total (287 PN 52-6800 and 278 PN 52- 6700) Z-0896-2013