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Class 2 Device Recall Foundation Total Knee System. |
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Date Initiated by Firm |
November 03, 2005 |
Date Posted |
December 29, 2005 |
Recall Status1 |
Terminated 3 on April 04, 2008 |
Recall Number |
Z-0331-06 |
Recall Event ID |
33991 |
510(K)Number |
K923277
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Product Classification |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
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Product |
Size 6 right Foundation Total Knee System (Catalog #324-01-106) knee joint replacement. |
Code Information |
Lot #426142 and #426132. |
Recalling Firm/ Manufacturer |
Encore Medical, Lp 9800 Metric Blvd Austin TX 78758
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Manufacturer Reason for Recall |
The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function.
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FDA Determined Cause 2 |
Other |
Action |
Firm initiated recall on 11/03/05 via letter to all consignees. |
Quantity in Commerce |
16 units. |
Distribution |
Device distributed to direct accounts in AZ, CA, FL, GA, MO, NJ, OK, SC, SD and TX. Foreign consignies located in Freiburg and Langelsheim, Germany. |
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 = JWH and Original Applicant = ENCORE ORTHOPEDICS, INC.
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