Class 2 Device Recall 3DKnee Tibial Insert

• Date Initiated by Firm: May 31, 2017
• Create Date: June 30, 2017
• Recall Status: Terminated on January 08, 2021
• Recall Number: Z-2659-2017
• Recall Event ID: 77435
• 510(K)Number: K091956
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: 3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 01 The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.
• Code Information: Lot # 339G1045
• Recalling Firm/ Manufacturer: Encore Medical, Lp; 9800 Metric Blvd; Austin TX 78758-5445
• For Additional Information Contact: Neeta Sharma ; 760-734-3551
• Manufacturer Reason for Recall: Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert.
• FDA Determined Cause: Packaging process control
• Action: The firm, DJO Global, sent an "URGENT FIELD SAFETY NOTICE" dated 5/31/2017 by email to its consignees on 5/31/2017. The notice described the product, problem and actions to be taken. The consignees were instructed to do the following actions by June 16, 2017: pass notice on to all those within the organization or to any organization where the affected product has been transferred; contact customer service at 1-800-456-8696 to place a replacement order and obtain shipment information; return all affected devices; and complete, sign and return the Acknowledgment and Receipt Form by email to: Desiree.Wells@djoglobal.com. The Regulatory Affairs department will follow-up via phone and email with non-responding consignees. If you have any questions, please contact Sr. Director Regulatory Affairs by phone at (760) 734-3551 or by email at Neeta.Sharma@djoglobal.com.
• Quantity in Commerce: 9 units
• Distribution: Worldwide Distribution-US (nationwide) to states of: AL, TX, UT, and CA; and countries of: INDIA and GERMANY.
• 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