Recall Z-0699-03 ยท HWC Screw, Fixation, Bone
Mitek Worldwide
Mitek Profile 8 x 20 mm Cannulated Interference Screw Round Head Product Reference No.: 230420
| Date | Apr 1, 2003 (initiated Feb 28, 2003) |
| Status | Terminated |
| Reason | Mislabeled product: Screw length incorrectly labeled may contain a 30 mm instead of 20 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 | 20 |
| 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
| K982662 | DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW DePuy Orthopaedics, Inc., Oct 28, 1998 |