Class 2 Device Recall Achillon minimally invasive Achilles tendon suture system

Date Initiated by Firm	July 02, 2004
Date Posted	July 31, 2004
Recall Status¹	Terminated ³ on July 05, 2005
Recall Number	Z-1304-04
Recall Event ID	29559
Product Classification	Suture Removal Kit - Product Code MCZ
Product	Achillon minimally invasive Achilles tendon suture system
Code Information	Product: Achillon Reference No.: 119 700 Batch No.: C Sterilization Batch No.: S037
Recalling Firm/ Manufacturer	Wright Medical Technology Inc 5677 Airline Road P.O. Box 100 Arlington TN 38002-0100
For Additional Information Contact	Robert W. Churinetz 901-867-4704
Manufacturer Reason for Recall	Lack of sterility assurance
FDA Determined Cause ²	Other
Action	Wright Medical Technology notified its consignees via email and telephone to ensure that the email was received. The consignees asked to return any in-stock recalled product to Wright Medical Technology.
Quantity in Commerce	20 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.