Mitek Worldwide
Profile 8 x 20 mm Cannulated Interference Screw Round Head Catalog Number: 230420
| Date | Jul 15, 2003 (initiated Jun 16, 2003) |
| Status | Terminated |
| Reason | Mislabeled -Incorrect Screw Size. The unit labeled 7x 25 mm screw may be a 8 x2 0 mm; and the unit labeled 8 x20mm may be a 7 X 25mm |
| Root cause | Other |
| Action | Mitek notified consignees by letter on 6/16/0 by US Mail Certified Return Receipt. The international affiliates were notified by email on 6/16/03. Users were requested to return product in inventory. |
| Quantity | 40 |
| Distribution | CA, FL, NJ, MO, NY, OR, TX, VA Foreign: Argentina, Australia, Japan, Arab Emirates, Portugal, spain |
| 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 |