Recall Z-1670-2009
DePuy Spine, Inc. · initiated February 11, 2009
Product
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.
Codes / lots: Product Code: 2894-10-300; Lot Number: 1208NT.
Reason for recall
Tip of Driver may break during use
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-1670-2009
- Initiated
- February 11, 2009
- Posted by FDA
- August 14, 2009
- Terminated
- July 9, 2015
- Product code
- KWP – Appliance, Fixation, Spinal Interlaminal
- Quantity
- 117 units
- Distribution
- Nationwide Distribution -- Including states of MD, PA, NC, MO, NV, AZ, WI and CT.
- Recalling firm
- DePuy Spine, Inc., Raynham, MA