Recall Z-1507-2016 ยท HWC Screw, Fixation, Bone
Stryker Howmedica Osteonics Corp.
VariAx Compression Plating System
| Date | Apr 18, 2016 (initiated Oct 10, 2013) |
| Status | Terminated |
| Reason | Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole. |
| Root cause | Device Design |
| Action | Stryker Orthopaedics sent notification letters/product accountability forms on October 10, 2013, via email. Customers are provided the product issue, hazards and risk mitigation along with actions needed. Customers should receive the affected products and complete the BRF and return to Stryker. Questions can be directed to Stryker. For further questions, please call (201) 831-5000. |
| Quantity | 118 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130009 | VARIAX 2 COMPRESSION PLATING SYSTEM Stryker Trauma AG, Mar 22, 2013 |