Profile 7 x 25 mm Cannulated Interference Screw Round Head Catalog Number: 230325
FDA device recall Z-1004-03 · posted 2003-07-15 · Terminated
Recall details
- Recalling firm
- Mitek Worldwide
- Reason for recall
- Mislabeled -Incorrect Screw Size. The unit labeled 7x 25 mm screw may be a 8 x2 0 mm; and the unit labeled 8 x20 mm may be a 7 X 25mm
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 40
- Distribution
- CA, FL, NJ, MO, NY, OR, TX, VA Foreign: Argentina, Australia, Japan, Arab Emirates, Portugal, spain
- Date initiated
- 2003-06-16
- Date posted
- 2003-07-15
- Date terminated
- 2003-10-22
- Location
- Norwood, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW (K982662) | DePuy Orthopaedics, Inc. | 1998-10-28 |