Class 2 Device Recall Guardian Distal Femur Axial Pin

• Date Initiated by Firm: July 14, 2004
• Date Posted: August 24, 2004
• Recall Status: Terminated on July 05, 2005
• Recall Number: Z-1405-04
• Recall Event ID: 29664
• 510(K)Number: K013035
• Product Classification: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented - Product Code JDI
• Product: Guardian Distal Femur Axial Pin
• Code Information: Part No. 25002111, Serial No. 02217952 Part No. 25002112, Serial No. 01214391 Part No. 25002112, Serial No. 01215073 Part No. 25002113, Serial No. 01214533 Part No. 25002114, Serial No. 01215034 Part No. 25002114, Serial No. 01215074
• 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: Potential for self -locking axial pin to dislodge and 'back out'.
• FDA Determined Cause: Other
• Action: The firm sent out product correction notifications to implanting surgeons by letter dated 07/14/2004 to notify the surgeons of the dislodgement issue.
• Quantity in Commerce: 44
• Distribution: Nationwide. Ontario, and Taiwan, ROC
• 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 = JDI