Class 2 Device Recall Gliding Nail

• Date Initiated by Firm: June 30, 2003
• Date Posted: December 08, 2007
• Recall Status: Terminated on December 13, 2007
• Recall Number: Z-0360-2008
• Recall Event ID: 45475
• 510(K)Number: K020240
• Product Classification: Metallic Bone Fixation - Product Code KTT
• Product: Plus Orthopedics Gliding Nail 17mm proximal / 11mm distal, 125 degrees, 180mm; Model Number: 0132073, Plus Orthopedics USA, San Diego, CA 92121
• Code Information: Model Number: 0132073, Lot Number : 024332
• FEI Number: 3001237832
• Recalling Firm/ Manufacturer: Plus Orthopedics USA; 10188 Telesis Ct; San Diego CA 92121-4779
• For Additional Information Contact: Clint Corona; 888-741-7587 Ext. 2526
• Manufacturer Reason for Recall: The device was produced without the required distal locking hole
• FDA Determined Cause: Reprocessing Controls
• Action: The initial depth of the withdrawal action taken in June, 2003 ,was to the distributor (agent) level. Plus USA contacted individual agent sites showing inventory of the affected article numbers on hand and requested that those items be returned to Plus USA.
• Quantity in Commerce: 3
• Distribution: Nationwide: AZ and ID
• 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 = KTT