2.0/2.4 Cannulated Screw Driver Bit, part #210-24-003
FDA device recall Z-1438-2010 · posted 2010-04-26 · Terminated
Recall details
- Recalling firm
- Trilliant Surgical LTD
- Reason for recall
- Firm received several complaints of field failures, e.g., "broke during surgery" and the firm initiated a design change. A communication to sales staff 04/14/2009 instructed them to recover and reconcile these products from user physicians.
- Action taken
- Firm notified sales force by e-mail on 4/14/2009 of the need to recover and reconcile this product . Additional documentation is not available from the firm. Questions may be directed directly to the firm at 800-495-2919.
- Root cause
- Other
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 32 units
- Distribution
- WI, TX, MO, NM, MN, OK, MA, CA, GA, ND, NE, IA, NY, LA, and MD
- Date initiated
- 2009-04-14
- Date posted
- 2010-04-26
- Date terminated
- 2010-05-03
- Location
- Houston, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TIGER CANNULATED SCREW SYSTEM (K081510) | Trilliant Surgical, Ltd. | 2008-08-04 |