Class 2 Device Recall Total knee implant

• Date Initiated by Firm: November 15, 2016
• Create Date: December 06, 2016
• Recall Status: Terminated on January 20, 2017
• Recall Number: Z-0711-2017
• Recall Event ID: 75715
• 510(K)Number: K143242
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: Empowr Knee System; ; Product Usage:; Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.
• Code Information: 033T1022
• Recalling Firm/ Manufacturer: Encore Medical, Lp; 9800 Metric Blvd; Austin TX 78758-5445
• For Additional Information Contact: 512-832-9500
• Manufacturer Reason for Recall: A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, marked with the lot number for the size 6 minus lot, and distributed as size 6 minus.
• FDA Determined Cause: Mixed-up of materials/components
• Action: The recalling firm sent an Urgent Field Safety Notice letter dated November 15, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions call 760-734-3551.
• Quantity in Commerce: 7 units
• Distribution: US Nationwide Distribution in the states of CO, IL, IN, FL, CA, AZ
• 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 MEDICAL, L.P.