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U.S. Department of Health and Human Services

Class 2 Device Recall Arthrocare

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  Class 2 Device Recall Arthrocare 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-0350-2008
Recall Event ID 44963
510(K)Number K052491  K060970  K051983  
Product Classification ParaFix Anchor - Product Code MBI
Product Arthrocare 6.5mm ParaFix Anchor, 2 strands of MagnumWire
Part Number: 22-5012, Axya Medical, Inc., Beverly, MA 01915

Code Information Lot Numbers: 204080, 204106, 204110, 204376, 204381, 204470, 204471 and 204608 
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 984 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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