Recall Z-1445-2008 ยท HWC Screw, Fixation, Bone
Integra LifeSciences Corp.
QWIX Screw 4.3mm diam; length 26 mm; The stabilization screw is indicated for fixation of bone fractures or for bone reconstruction.
| Date | Aug 15, 2008 (initiated Feb 27, 2008) |
| Status | Terminated |
| Reason | Certain QWIX Fixation Screws (Reference numbers 111426S and 111428S) have been etched and labelled with an incorrect length. |
| Root cause | Labeling mix-ups |
| Action | 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. |
| Quantity | 42 units |
| Distribution | Nationwide Distribution --- including states of NC, IL, CA, NC and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050346 | STABILIZATION SCREW New Deal, S.A., Mar 17, 2005 |