Device 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.
Z-0685-2013
Product summary
- Event
- Event 62719
- Status
- Terminated
- Classification
- Class II
- Quantity
- 140 units
- Official record key
device-enforcement:Z-0685-2013
Official wording
Reason: 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.
Code information: All lots
Distribution pattern: Worldwide Distribution - USA (nationwide) and internationally to Belgium, Egypt, Ireland, Italy, Portugal, and the UK.
Derived failure modes
-
Unknown
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.