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U.S. Department of Health and Human Services

Enforcement Report - Week of January 23, 2013

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Product Detail

Product Description DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the final tightening of an Expedium Offset Spinal Construct.
Recall Number Z-0685-2013
Classification Class II
Code Info All lots
Product Distributed Qty 140 units
Reason For Recall A component within the handle of the Expedium Offset Torque Wrench is prematurely wearing, potentially resulting in the instrument recording torque values outside of the specification.

Event Detail

Event Id 62719
Product Type Devices
Status Ongoing
Recalling Firm DePuy Spine, Inc.
City Raynham
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-24
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) and internationally to Belgium, Egypt, Ireland, Italy, Portugal, and the UK.