FDA Recall
Terminated
DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft, Non-Sterile, REF: 2894-10-300. Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine.
Recall: Z-1670-2009
·
Initiated February 11, 2009
Recall
- Recall Number
- Z-1670-2009
- Event Number
- 51138
- Firm
- DePuy Spine, Inc.
- FEI Number
- 1526439
- Product Code
- KWP
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- February 11, 2009
- Posted
- August 14, 2009
- Terminated
- July 9, 2015
- Address
- 325 Paramount Drive, Raynham, MA, 02767
Description
DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft, Non-Sterile, REF: 2894-10-300. Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine.
Reason
Tip of Driver may break during use
Action
DePuy Spine notified direct accounts by visit and distributors by letter titled "Urgent - Voluntary Product Recall Notification". Accounts are requested to return the notification fax form and all affected product. For further questions, contact Depuy Spine at 1-800-227-6633.
Distribution
Nationwide Distribution -- Including states of MD, PA, NC, MO, NV, AZ, WI and CT.
Quantity
117 units