Recall Z-0685-2013 ยท HXC Wrench
DePuy Spine, Inc.
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.
| Date | Jan 16, 2013 (initiated Jul 24, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 140 units |
| Distribution | Worldwide Distribution - USA (nationwide) and internationally to Belgium, Egypt, Ireland, Italy, Portugal, and the UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.