Class 2 Device Recall Newdeal Qwix Fixation Screw

• Date Initiated by Firm: February 27, 2008
• Date Posted: August 15, 2008
• Recall Status: Terminated 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
• FEI Number: 3003418325
• 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 (Part numbers 111426s and 111428s) have been etched and labelled with an incorrect length.
• FDA Determined Cause: 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