Class 2 Device Recall Axya

• Date Initiated by Firm: September 27, 2007
• Date Posted: December 08, 2007
• Recall Status: Terminated 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
• FEI Number: 3000718467
• 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: 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.