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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-0336-2008
Recall Event ID 44963
Product Classification Anchor - Product Code MBI
Product Axya Anchor, 5.0 mm Titanium in Super Kit,
Catalog Number: CAT1270, Axya Medical, Inc., Beverly, MA 01915
Code Information Lot Numbers: 203415, 203445, 203588, 203604, 203739, 203742, 203791, 203798, 203820, 203823, 203834, 203863, 203905, 203915, 203994, 204025, 204126, 204176, 204187, 204199, 204209, 204239, 204246, 204277, 204302, 204308, 204350, 204355, 204390, 204459,204482, 204511, 204513, 204516, 204521, 204546, 204626, 204642, 204646, 204651,204673, 204692, 204721, 204736, and 204781 
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 208 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.
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