QWIX Screw 4.3mm diam, length 28 mm; The stabilization screw is indicated for fixation of bone fractures or for bone rec
FDA device recall Z-1446-2008 · posted 2008-08-15 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- Certain QWIX Fixation Screws (Part numbers 111426s and 111428s) have been etched and labelled with an incorrect length.
- Action taken
- Integra Reps were sent recall notification with a recall acknowledgement on 2/27/2008. The customers who were shipped affected product were also notified on that date.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 20 units
- Distribution
- Nationwide Distribution --- including states of NC, IL, CA, NC and TX.
- Date initiated
- 2008-02-27
- Date posted
- 2008-08-15
- Date terminated
- 2008-08-21
- Location
- Plainsboro, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STABILIZATION SCREW (K050346) | New Deal, S.A. | 2005-03-17 |