PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: January 23, 2013 Initiated: July 24, 2012 #Z-0685-2013

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.

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.

Details

Recalling Firm
DePuy Spine, Inc.
Units Affected
140 units
Distribution
Worldwide Distribution - USA (nationwide) and internationally to Belgium, Egypt, Ireland, Italy, Portugal, and the UK.
Location
Raynham, MA

Frequently Asked Questions

What product was recalled?
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.. Recalled by DePuy Spine, Inc.. Units affected: 140 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 23, 2013. Severity: Moderate. Recall number: Z-0685-2013.