Date Initiated by Firm |
September 27, 2007 |
Date Posted |
December 08, 2007 |
Recall Status1 |
Terminated 3 on June 21, 2012 |
Recall Number |
Z-0337-2008 |
Recall Event ID |
44963 |
510(K)Number |
K052491 K060970 K051983
|
Product Classification |
Bone Anchor - Product Code MBI
|
Product |
Axya Bone Anchor 3.0 mm Titanium in Super Kit Catalog Number: CAT1274, Axya Medical, Inc., Beverly, MA 01915 |
Code Information |
Lot Numbers: 204951, and 204957 |
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 |
4 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.
|