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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 Recall
DePuy Spine EXPEDIUM Offset Torque Wrench
see related information
Date Posted January 16, 2013
Recall Status1 Terminated on December 30, 2013
Recall Number Z-0685-2013
Recall Event ID 62719
Product Classification Wrench - Product Code HXC
Product 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.
Code Information All lots
Recalling Firm/
Manufacturer
DePuy Spine, Inc.
325 Paramount Dr
Raynham, Massachusetts 02767-5199
For Additional Information Contact Linda 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
OTHER/UNDETERMINED: Under Investigation by the firm
Action DePuy 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 Commerce 140 units
Distribution Worldwide Distribution - USA (nationwide) and internationally to Belgium, Egypt, Ireland, Italy, Portugal, and the UK.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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