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Class 2 Device Recall CONSERVE, TOTAL ACLASS Femoral Head |
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Date Initiated by Firm |
May 14, 2009 |
Create Date |
June 25, 2015 |
Recall Status1 |
Terminated 3 on December 09, 2009 |
Recall Number |
Z-1716-2009 |
Recall Event ID |
52217 |
510(K)Number |
K051348
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Product Classification |
Prosthesis, hip, semi-constrained (metal cemented acetabular component) - Product Code JDL
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Product |
CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3635, 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: 029798202. |
Recalling Firm/ Manufacturer |
Wright Medical Technology Inc 5677 Airline Rd Arlington TN 38002
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For Additional Information Contact |
Debbie Daurer 901-867-4601
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Manufacturer Reason for Recall |
Incorrect packaging, swapped sizes
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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 |
15 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
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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.
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510(K) Database |
510(K)s with Product Code = JDL and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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