Mitek M. Kurosaka Advantage 7 X 30 mm Cannulated Fixation Screw Product Reference No.: 230030
FDA device recall Z-0696-03 · posted 2003-04-01 · Terminated
Recall details
- Recalling firm
- Mitek Worldwide
- Reason for recall
- Mislabeled product: Screw length incorrectly labeled may contain a 20 mm instead of 30 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
- 4
- 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 |
|---|---|---|
| M. KUROSAKA INTERFERENCE FIXATION SCREW (K933738) | Depuy, Inc. | 1994-02-23 |