Class 2 Device Recall 3DKnee System

• Date Initiated by Firm: June 28, 2010
• Date Posted: August 22, 2010
• Recall Status: Terminated 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/ Manufacturer: Encore Medical, Lp; 9800 Metric Blvd; Austin TX 78758
• For Additional Information Contact: 512-834-6275
• 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: 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.