Recall Z-0433-2010
Stryker Spine · initiated October 2, 2009
Product
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 52MM, spinal implant component
Codes / lots: Catalog number 48036052, all lots
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.
FDA-determined 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.
Details
- Recall number
- Z-0433-2010
- Initiated
- October 2, 2009
- Posted by FDA
- November 24, 2009
- Terminated
- January 23, 2013
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Quantity
- 176
- Distribution
- Nationwide
- Recalling firm
- Stryker Spine, Allendale, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0423-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 22MM, spinal…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0424-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 25MM, spinal…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0425-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 28MM, spinal…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0426-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 31MM, spinal…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0427-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 34MM, spinal…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0428-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 37MM, spinal…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0429-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 40MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0430-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 43MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0431-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 46MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0432-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 49MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0434-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 55MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0435-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 58MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0436-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 61MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0437-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 64MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0438-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 67MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0439-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 22MM, spinal…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0440-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 25MM, spinal…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0441-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 28MM, spinal…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0442-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 31MM, spinal…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0443-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 34MM, spinal…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0444-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 37MM, spinal…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0445-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 40MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0446-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 43MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0447-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 46MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0448-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 49MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0449-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 52MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0450-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 55MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0451-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 58MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0452-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 61MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |
| Z-0453-2010 | Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 64MM…Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting… | 10/02/2009Terminated |