Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 37MM, spinal implant component
FDA device recall Z-0444-2010 · posted 2009-11-24 · Terminated
Recall details
- Recalling firm
- Stryker Spine
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- 257
- Distribution
- Nationwide
- Date initiated
- 2009-10-02
- Date posted
- 2009-11-24
- Date terminated
- 2013-01-23
- Location
- Allendale, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THOR ANTERIOR PLATING SYSTEM (K073437) | Stryker Spine | 2008-02-13 |