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U.S. Department of Health and Human Services

Class 2 Device Recall 3DKnee System

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  Class 2 Device Recall 3DKnee System see related information
Date Initiated by Firm June 28, 2010
Date Posted August 22, 2010
Recall Status1 Terminated 3 on October 04, 2010
Recall Number Z-2244-2010
Recall Event ID 56200
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/
Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
For Additional Information Contact
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
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 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 = JWH and Original Applicant = ENCORE ORTHOPEDICS, INC.