Recall Z-0685-2013— DePuy Spine, Inc.
Class II · Terminated
Class II FDA medical device recall by DePuy Spine, Inc., initiated 2012-07-24, terminated 2013-12-30. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- DePuy Spine, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-07-24
- Terminated
- 2013-12-30
- Firm location
- Raynham, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.