FDA-Device2013-01-23Class II
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.
DePuy Spine, Inc.
Hazard
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.
Sold states
Worldwide Distribution - USA (nationwide) and internationally to Belgium, Egypt, Ireland, Italy, Portugal, and the UK.
Affected count
140 units
Manufactured in
325 Paramount Dr, N/A, Raynham, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0685-2013Don't want to check this manually?
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