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U.S. Department of Health and Human Services

Class 2 Device Recall Newdeal Qwix Fixation Screw

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  Class 2 Device Recall Newdeal Qwix Fixation Screw see related information
Date Initiated by Firm February 27, 2008
Date Posted August 15, 2008
Recall Status1 Terminated 3 on August 21, 2008
Recall Number Z-1446-2008
Recall Event ID 47244
510(K)Number K050346  
Product Classification Bone Fixation Screw - Product Code HWC
Product QWIX Screw 4.3mm diam, length 28 mm; The stabilization screw is indicated for fixation of bone fractures or for bone reconstruction.
Code Information Catalog Number 222428S; Lot E54R
Recalling Firm/
Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Karen Tuley
Manufacturer Reason
for Recall
Certain QWIX Fixation Screws (Part numbers 111426s and 111428s) have been etched and labelled with an incorrect length.
FDA Determined
Cause 2
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 in Commerce 20 units
Distribution Nationwide Distribution --- including states of NC, IL, CA, NC and TX.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = NEWDEAL S.A.