Recall Z-0697-03 ยท HWC Screw, Fixation, Bone
Mitek Worldwide
Mitek M. Kurosaka Advantage 9 X 30 mm Cannulated Fixation Screw Product Reference No.: 230120
| Date | Apr 1, 2003 (initiated Feb 28, 2003) |
| Status | Terminated |
| Reason | Mislabeled product: Screw length incorrectly labeled may contain a 20 mm instead of 30 mm |
| Root cause | Other |
| Action | Mitek Worldwide notified domestic accounts by US Mail on 2/28/03. The International affiliates were sent notifications by Federal Express on 2/28/03. |
| Quantity | 29 |
| Distribution | CO, FL, MN, PA, TX International- Mitek Affiliates: Australia, Columbia, Japan UK, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K933738 | M. KUROSAKA INTERFERENCE FIXATION SCREW Depuy, Inc., Feb 23, 1994 |