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U.S. Department of Health and Human Services

Class 2 Device Recall 3DKnee System

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 Class 2 Recall
3DKnee System
see related information
Date Posted August 22, 2010
Recall Status1 Terminated on October 04, 2010
Recall Number Z-2244-2010
Recall Event ID 56200
Premarket Notification
510(K) Number
K020114 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product 3DKnee Baseplates, Size 8, Left, Part # 333-01-108, Lot# A1000003.
Code Information Size 8, Left, Part # 333-01-108, Lot# A1000003
Recalling Firm/
Manufacturer
Encore Medical, Lp
9800 Metric Blvd
Austin, Texas 78758
Consumer Instructions Contact the recalling firm for information Contact the recalling firm for information
Manufacturer Reason
for Recall
One lot of product has an incorrect color label. The color label is a secondary visual indicator of sizing.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action Firm notified their consignees by letter on June 28, 2010.
Quantity in Commerce 18
Distribution Florida, Missouri, and Italy
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = ENCORE ORTHOPEDICS, INC.
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