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.
- Company
- Depuy Spine, Inc.
- Recall Initiated
- February 11, 2009
- Posted
- August 14, 2009
- Terminated
- July 9, 2015
- Recall Number
- Z-1670-2009
- Quantity
- 117 units
- Firm Location
- Raynham, MA
Reason for Recall
Tip of Driver may break during use
Distribution
Nationwide Distribution -- Including states of MD, PA, NC, MO, NV, AZ, WI and CT.
Lot / Code Info
Product Code: 2894-10-300; Lot Number: 1208NT.
Root 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.
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