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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Profemur R, Revision Hip system, Proximal Body (part), see related information
Date Initiated by Firm March 27, 2007
Date Posted June 07, 2007
Recall Status1 Terminated 3 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/
Wright Medical Technology Inc
5677 Airline Road
PO Box 100
Arlington TN 38002-0100
For Additional Information Contact Debbie Daurer
Manufacturer Reason
for Recall
The titanium plasma coating was found to have missing fragments.
FDA Determined
Cause 2
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 and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.