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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 Recall
Newdeal Qwix Fixation Screw
see related information
Date Posted August 15, 2008
Recall Status1 Terminated on August 21, 2008
Recall Number Z-1445-2008
Recall Event ID 47244
Premarket Notification
510(K) Number
K050346 
Product Classification Screw, Fixation, Bone - 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, New Jersey 08536-3344
Consumer Instructions Contact the recalling firm for information
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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = NEWDEAL S.A.
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