Class 2 Device Recall ATTUNE Rotating Platform (RP) Total Knee System

• Date Initiated by Firm: February 22, 2021
• Create Date: March 29, 2021
• Recall Status: Terminated on October 11, 2023
• Recall Number: Z-1316-2021
• Recall Event ID: 87433
• PMA Number: P830055S225
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing - Product Code NJL
• Product: The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.
• Code Information: Lot: 9557372, Product Code: 150680003, GTIN: 10603295492153 Lot: 9557439, Product Code: 150680003, GTIN: 10603295492153 Lot: 9557440, Product Code: 150680003, GTIN: 10603295492153 Lot: 9557450, Product Code: 150680003, GTIN: 10603295492153 Lot: 9557460, Product Code: 150680003, GTIN: 10603295492153 Lot: 9557444, Product Code: 150680004, GTIN: 10603295492160 Lot: 9557445, Product Code: 150680004, GTIN: 10603295492160 Lot: 9557446, Product Code: 150680004, GTIN: 10603295492160 Lot: 9557453, Product Code: 150680004, GTIN: 10603295492160 Lot: 9557455, Product Code: 150680004, GTIN: 10603295492160 Lot: 9557376, Product Code: 150680005, GTIN: 10603295492177 Lot: 9557377, Product Code: 150680005, GTIN: 10603295492177 Lot: 9557457, Product Code: 150680005, GTIN: 10603295492177 Lot: 9557471, Product Code: 150680005, GTIN: 10603295492177 Lot: 9557473, Product Code: 150680005, GTIN: 10603295492177 Lot: 9557476, Product Code: 150680005, GTIN: 10603295492177 Lot: 9556100. Product Code: 150680006, GTIN: 10603295492184 Lot: 9556127, Product Code: 150680006, GTIN: 10603295492184 Lot: 9556128, Product Code: 150680006, GTIN: 10603295492184 Lot: 9557434, Product Code: 150680007, GTIN: 10603295492191
• Recalling Firm/ Manufacturer: DePuy Orthopaedics, Inc.; 700 Orthopaedic Dr; Warsaw IN 46582-3994
• For Additional Information Contact: Kimberly Long; 574-221-8156
• Manufacturer Reason for Recall: Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.
• FDA Determined Cause: Packaging change control
• Action: On 02/25/2021, Depuy Synthes issued an Urgent Medical Device Recall notices to customers via email. DePuy (Ireland) UC is initiating a voluntary removal for the 12 lots for ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.
• Quantity in Commerce: 355 units total (Domestic: 177 units, Foreign: 178 units)
• Distribution: Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Brazil, Austria, Belgium, Denmark, Estonia, France, Germany, Great Britain, Ireland, Israel, Italy, Macedonia, Mauritius, Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, South Africa, Sweden, Switzerland, United Arab Emirates, China, Hong Kong, Japan, New Zealand, Korea, Singapore, Thailand.
• 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.

• PMA Database: PMAs with Product Code = NJL and Original Applicant = DEPUY, INC.