Recall Z-0685-2013
DePuy Spine, Inc. · initiated July 24, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: All lots
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.
FDA-determined cause: Device Design
Action taken
DePuy Spine issued an Urgent - Voluntary Product Recall Notification dated July 24, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to disconstinue the use of the affected product and to remove the EXPEDIUM Offset Torque Wrenches from service and return to DePuy Synthes Spine until direction can be provided by DePuy Synthes Spine regarding a replacement torque limiting device. For questions regarding this recall call 508-828-3769.
Details
- Recall number
- Z-0685-2013
- Initiated
- July 24, 2012
- Posted by FDA
- January 16, 2013
- Terminated
- December 30, 2013
- Product code
- HXC – Wrench
- Quantity
- 140 units
- Distribution
- Worldwide Distribution - USA (nationwide) and internationally to Belgium, Egypt, Ireland, Italy, Portugal, and the UK.
- Recalling firm
- DePuy Spine, Inc., Raynham, MA