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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-0354-2008
Recall Event ID 44963
510(K)Number K052491  K060970  K051983  
Product Classification Sutures - Product Code MBI
Product Arthrocare 6.5 mm ParaSorb, Preloaded with 2
MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5065, Axya Medical, Inc., Beverly, MA 01915
Code Information Lot Numbers: 203767 203769 203809 203829 203839 203940 203941 203942 203953 203965 203966 203967 203968 204010 204018 204019 204130 204236 204242 204250 204251 204252 204284 204285 204286 204292 204293 204294 204295 204314 204315 204316 204356 204357 204358 204359 204360 204361 204368 204377 204379 204380 204400 204401 204412 204433 204434 204437 204438 204609 204610 204611 204624 204657 204667 204668 and  204669 
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 1,538 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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