Skip to content
Recall Observatory FDA recall evidence

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

July 24, 2012

Class II

Product summary

Firm
DePuy Spine, Inc.
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

    reason.no_named_rule · v1.0.0

    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.