QWIX Screw 4.3mm diam; length 26 mm; The stabilization screw is indicated for fixation of bone fractures or for bone reconstruction.
This recall has been terminated (originally issued August 15, 2008).
- Company
- Integra Lifesciences Corp.
- Recall Initiated
- February 27, 2008
- Posted
- August 15, 2008
- Terminated
- August 21, 2008
- Recall Number
- Z-1445-2008
- Quantity
- 42 units
- Firm Location
- Plainsboro, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Certain QWIX Fixation Screws (Reference numbers 111426S and 111428S) have been etched and labelled with an incorrect length.
Distribution
Nationwide Distribution --- including states of NC, IL, CA, NC and TX.
Lot / Code Info
Catalog number: 111426S; Lot E54Q
Root Cause
Labeling mix-ups
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.