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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-1445-2008
Recall Event ID 47244
510(K)Number K050346  
Product Classification Bone Fixation Screw - Product Code HWC
Product QWIX Screw 4.3mm diam; length 26 mm; The stabilization screw is indicated for fixation of bone fractures or for bone reconstruction.
Code Information Catalog number: 111426S; Lot E54Q
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Karen Tuley
609-275-0500
Manufacturer Reason
for Recall		 Certain QWIX Fixation Screws (Reference 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 42 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.
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