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U.S. Department of Health and Human Services

Class 2 Device Recall Arthrocare, ParaSorb

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  Class 2 Device Recall Arthrocare, ParaSorb see related information
Date Initiated by Firm September 27, 2007
Date Posted December 08, 2007
Recall Status1 Terminated 3 on June 21, 2012
Recall Number Z-0352-2008
Recall Event ID 44963
510(K)Number K052491  K060970  K051983  
Product Classification Sutures - Product Code MBI
Product Arthrocare 5.5mm ParaSorb, pre-loaded with 2
MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5055 , Axya Medical, Inc., Beverly, MA 01915
Code Information Lot Numbers:  203766 203768 203788 203857 203858 203859 203879 203884 203885 203918 203919 203925 203931 203932 203969 204009 204129 204174 204185 204186 204218 204219 204224 204234 204235 204240 204241 204257 204258 204259 204267 204268 204269 204274 204275 204276 204296 204311 204312 204313 204324 204325 204326 204327 204328 204329 204382 204429 204456 204457 204597 204598 204606 204615 204616 204617 204618 204699 204700 204701 and  204702 
Recalling Firm/
Manufacturer		 Axya Medical
100 Cummings Ctr Ste 444c
Beverly MA 01915-6132
For Additional Information Contact SAME
978-232-9997 Ext. 647
Manufacturer Reason
for Recall		 Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
FDA Determined
Cause 2		 Package design/selection
Action Axya Medical notified customers by letter, Urgent-Product Recall, dated 9/25/07 , via UPS . Users are requested to return product and complete the reply form.
Quantity in Commerce 4,091 units
Distribution Nationwide
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 = MBI and Original Applicant = AXYA MEDICAL, INC.
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