Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Re
FDA device recall Z-2456-2015 · posted 2015-08-24 · Terminated
Recall details
- Recalling firm
- Trilliant Surgical Ltd.
- Reason for recall
- The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to freely pass through.
- Action taken
- The recalling firm sent out written notification of the recall on 7/3/14. The letter instructed the consignees to exchange affected instruments.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- HTO
- Quantity affected
- 638 units
- Distribution
- Nationwide throughout the US
- Date initiated
- 2015-07-20
- Date posted
- 2015-08-24
- Date terminated
- 2017-01-26
- 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 |
|---|---|---|
| GRIDLOCK PLATING SYSTEM (K121452) | Trilliant Surgical, Ltd. | 2012-08-20 |