Date Initiated by Firm |
February 08, 2010 |
Date Posted |
April 07, 2010 |
Recall Status1 |
Terminated 3 on October 27, 2011 |
Recall Number |
Z-1253-2010 |
Recall Event ID |
54618 |
510(K)Number |
K050346
|
Product Classification |
Screw, Fixation, Bone - Product Code HWC
|
Product |
Qwix 4.3mm Stabilization Screws - 32mm |
Code Information |
Part Number: 111432SND Lot Number: E6CZ |
Recalling Firm/ Manufacturer |
Integra LifeSciences Corporation 4900 Charlemar Dr Bldg A Cincinnati OH 45227-1402
|
For Additional Information Contact |
513-533-7923
|
Manufacturer Reason for Recall |
The screws were etched incorrectly as 34mm instead of the correct 32mm.
|
FDA Determined Cause 2 |
Labeling mix-ups |
Action |
Consignees were notified via conference calls and/or FedEx mailing. Recall aknowledgement forms were provided with written notification. This requires consignees to review their inventory and to indicate any affected lots . This form requires a signature and must be returned. |
Distribution |
Nationwide distribution - Alabama, Arizona, Colorado, Connecticut, Maryland, Michigan, New England, New Jersey, North Carolina, Ohio, South Carolina, Nebraska, and Utah. |
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.
|