Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 52MM, spinal implant component
This recall has been terminated (originally issued November 24, 2009).
- Company
- Stryker Spine
- Recall Initiated
- October 2, 2009
- Posted
- November 24, 2009
- Terminated
- January 23, 2013
- Recall Number
- Z-0449-2010
- Quantity
- 165
- Firm Location
- Allendale, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide
Lot / Code Info
Catalog number 48036552, all lots
Root Cause
Device Design
Action Taken
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.