Recall Z-1670-2009 ยท KWP Appliance, Fixation, Spinal Interlaminal
DePuy Spine, Inc.
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.
| Date | Aug 14, 2009 (initiated Feb 11, 2009) |
| Status | Terminated |
| Reason | Tip of Driver may break during use |
| Root cause | Nonconforming Material/Component |
| 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. |
| Quantity | 117 units |
| Distribution | Nationwide Distribution -- Including states of MD, PA, NC, MO, NV, AZ, WI and CT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070300 | EXPEDIUM SFX CROSS CONNECTOR SYSTEM Depuy Spine, Inc., Apr 10, 2007 |