Recall Z-1250-2010 ยท HWC Screw, Fixation, Bone
Orthohelix Surgical Designs Inc
MaxTorque Cannulated Screw Model # MSD-010-55-060S
| Date | Apr 6, 2010 (initiated Apr 7, 2009) |
| Status | Terminated |
| Reason | A pinhead sized disc was found in the cannulation of a MSD-010-55-60S screw. |
| Root cause | Other |
| Action | On April 7, 2009 the firm sent letters to their customers with detailed instructions on how to correct the problem. Pictures were included for clarification. For questions please contact either Jim Bragg via phone at 330-869-9562 ext 211 or Kristin Wolff at ext 209. |
| Quantity | 45 pieces |
| Distribution | Product was delivered to: CA, CO, GA, NM, NY, OH, VA & WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060428 | CSS CANNULATED SCREW SYSTEM Orthohelix Surgical Designs, Inc., Mar 7, 2006 |