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U.S. Department of Health and Human Services

Class 2 Device Recall Qwix 4.3mm Stabilization Screws 34mm

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  Class 2 Device Recall Qwix 4.3mm Stabilization Screws 34mm see related information
Date Initiated by Firm February 08, 2010
Date Posted April 07, 2010
Recall Status1 Terminated 3 on October 27, 2011
Recall Number Z-1254-2010
Recall Event ID 54618
510(K)Number K050346  
Product Classification Screw, Fixation, Bone - Product Code HWC
Product Qwix 4.3mm Stabilization Screws - 34mm
Code Information Part Number: 111434SND  Lot Number: E6DO
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 32mm instead of the correct 34mm length.
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.
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