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U.S. Department of Health and Human Services

Enforcement Report - Week of January 23, 2013

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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
Distribution Pattern Worldwide Distribution - USA (nationwide) and internationally to Belgium, Egypt, Ireland, Italy, Portugal, and the UK.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. All lots Class II 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. 140 units Z-0685-2013