Mitek Profile 8 x 20 mm Cannulated Interference Screw Round Head Product Reference No.: 230420
FDA device recall Z-0699-03 · posted 2003-04-01 · Terminated
Recall details
- Recalling firm
- Mitek Worldwide
- Reason for recall
- Mislabeled product: Screw length incorrectly labeled may contain a 30 mm instead of 20 mm
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 20
- Distribution
- CO, FL, MN, PA, TX International- Mitek Affiliates: Australia, Columbia, Japan UK,
- Date initiated
- 2003-02-28
- Date posted
- 2003-04-01
- Date terminated
- 2004-02-04
- 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 |