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U.S. Department of Health and Human Services

Class 2 Device Recall CONSERVE, TOTAL ACLASS Femoral Head

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  Class 2 Device Recall CONSERVE, TOTAL ACLASS Femoral Head see related information
Date Initiated by Firm May 14, 2009
Create Date June 25, 2015
Recall Status1 Terminated 3 on December 09, 2009
Recall Number Z-1715-2009
Recall Event ID 52217
510(K)Number K051348  
Product Classification Prosthesis, hip, semi-constrained (metal cemented acetabular component) - Product Code JDL
Product CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3604, O.D. Size: 36mm, Neck Length: -3.5mm, Taper: SLT, Sterile R, 1 each, Rx only, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002.

The CONSERVE Total Femoral Head is indicated for use in total hip arthroplasty for reduction of relief of pain and/or improved hip function in skeletally mature patients.
Code Information Lot Number: 029798201.
Recalling Firm/
Manufacturer		 Wright Medical Technology Inc
5677 Airline Rd
Arlington TN 38002
For Additional Information Contact Debbie Daurer
901-867-4601
Manufacturer Reason
for Recall		 Incorrect packaging, swapped sizes
FDA Determined
Cause 2		 Packaging process control
Action Wright Medical Technology, Inc. notified hospitals, surgeons and their distributors of the recall situation via an "Urgent: Medical Device Voluntary Recall" notice dated May 14, 2009 explaining the problem, the hazard involved and requesting confirmation that the product was removed from their inventory. The letter included a "Fax Back" response page to ensure the receipt of the notice. For further questions, contact Wright Medical Technologies, Inc. at 1-800-874-5630.
Quantity in Commerce 14 units
Distribution Worldwide Distribution -- Including states of NC, TN, IA, IN, MD, WI, WV, OK, WA, PA, TN, TX, FL and CA and country of Canada.
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 = JDL and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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