Class 2 Device Recall Profemur R, Revision Hip system, Proximal Body (part),

• Date Initiated by Firm: March 27, 2007
• Date Posted: June 07, 2007
• Recall Status: Terminated on June 30, 2008
• Recall Number: Z-0868-2007
• Recall Event ID: 37826
• 510(K)Number: K003016
• Product Classification: hip prosthesis - Product Code LZO
• Product: Profemur R, Revision Hip system, Proximal Body (part), STD 4, REF: PPW38354, Cementless, Titanium Plasma Spray Coated, Sterile, Rx only. Hip implant.
• Code Information: Lot No. W09350601
• Recalling Firm/ Manufacturer: Wright Medical Technology Inc; 5677 Airline Road; PO Box 100; Arlington TN 38002-0100
• For Additional Information Contact: Debbie Daurer; 901-867-4601
• Manufacturer Reason for Recall: The titanium plasma coating was found to have missing fragments.
• FDA Determined Cause: Other
• Action: The firm sent out recall notices to implanting surgeons by letter dated 03/27/2007 (via FedEx) to notify the surgeons of the issue. The hospitals and distributors were also notified of the issue and given instructions for return of the product.
• Quantity in Commerce: 4 units
• Distribution: Nationwide, Puerto Rico, & Japan
• 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 = LZO