QWIX Screw 4.3mm diam, length 28 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-1446-2008
- Quantity
- 20 units
- Firm Location
- Plainsboro, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Certain QWIX Fixation Screws (Part 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 222428S; Lot E54R
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.