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U.S. Department of Health and Human Services

Class 2 Device Recall DePuy Spine EXPEDIUM Offset Torque Wrench

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 Class 2 Device Recall DePuy Spine EXPEDIUM Offset Torque Wrenchsee related information
Date Initiated by FirmJuly 24, 2012
Date PostedJanuary 16, 2013
Recall Status1 Terminated 3 on December 30, 2013
Recall NumberZ-0685-2013
Recall Event ID 62719
Product Classification Wrench - Product Code HXC
ProductDePuy 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.
Code Information All lots
Recalling Firm/
Manufacturer		 DePuy Spine, Inc.
325 Paramount Dr
Raynham MA 02767-5199
For Additional Information ContactLinda Regan
508-828-3769
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionDePuy Spine issued an Urgent - Voluntary Product Recall Notification dated July 24, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to disconstinue the use of the affected product and to remove the EXPEDIUM Offset Torque Wrenches from service and return to DePuy Synthes Spine until direction can be provided by DePuy Synthes Spine regarding a replacement torque limiting device. For questions regarding this recall call 508-828-3769.
Quantity in Commerce140 units
DistributionWorldwide Distribution - USA (nationwide) and internationally to Belgium, Egypt, Ireland, Italy, Portugal, and the UK.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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