Recall Z-0443-2010 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Stryker Spine
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 34MM, spinal implant component
| Date | Nov 24, 2009 (initiated Oct 2, 2009) |
| Status | Terminated |
| Reason | Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break at the tip. |
| Root cause | Device Design |
| Action | Recall notification letters were sent to all Stryker branches, Hospital Risk Management and Surgeons on October 19, 2009 by Federal Express. Questions are to be directed to Tiffani Rogers, Regulatory Compliance Manager at 201-760-8206. |
| Quantity | 262 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073437 | THOR ANTERIOR PLATING SYSTEM Stryker Spine, Feb 13, 2008 |