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
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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/ 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 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 |
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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.
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510(K) Database | 510(K)s with Product Code = HWC
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