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U.S. Department of Health and Human Services

Class 2 Device Recall Axya

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  Class 2 Device Recall Axya 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-0341-2008
Recall Event ID 44963
510(K)Number K052491  K060970  K051983  
Product Classification Bone Anchor - Product Code MBI
Product Axya Bone Anchor 6.5 mm Bioabsorbable with Nylon Suture
Catalog Number: CAT1265, Axya Medical, Inc., Beverly, MA 01915
Code Information Lot Numbers:  204073 and 205634 
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 35 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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