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-0342-2008
• Recall Event ID: 44963
• 510(K)Number: K051983 K052491 K060970
• Product Classification: Bone Anchor - Product Code MBI
• Product: Axya Bone Anchor 3.0 mm Bioabsorbable with UHMWPE Suture,Catalog Number: CAT1266, Axya Medical, Inc., Beverly, MA 01915
• Code Information: Lot Numbers: 204677, 204800, 204826 and 204838
• 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: 111 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