Class 2 Device Recall DJO EMPOWR KNEE Punch Handle

• Date Initiated by Firm: August 03, 2020
• Date Posted: October 07, 2020
• Recall Status: Open, Classified
• Recall Number: Z-0060-2021
• Recall Event ID: 86257
• 510(K)Number: K171991
• Product Classification: Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
• Product: DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage: The Tibial Punch Handle is used in conjunction with one of three appropriately sized Tibial Punch Guides to broach the tibial canal in preparation for the tibial baseplate keel.
• Code Information: Model/Catalog no. 801-05-040; :Lot/serial No.s 281905L08, 281905L15, 283808L01, 305197L02, 318871L10 Model/Catalog no. 801-05-018, Lot/serial No.s: 215488L08, 236760L01, 228231L01, 241946L02, 259710L01, 314969L01
• Recalling Firm/ Manufacturer: Encore Medical, LP; 9800 Metric Blvd; Austin TX 78758-5445
• For Additional Information Contact: 512-834-6200
• Manufacturer Reason for Recall: There is a potential for the retaining pin of the tibial punch handle to become loose and fall out while impacting. If undetected, there is a potential of leaving debris in the joint space.
• FDA Determined Cause: Process change control
• Action: On August 3, 2020, Field Safety Notices were sent to the firm's distributors by email advising them of this field action, informing them that the firm has received two product complaints where an issue has been experienced with the retaining pin becoming loose and falling out while impacting. Distributors were informed that no adverse events have been reported but that there is a potential of leaving debris in the joint space if this issue were to occur and remain undetected. The letter requests distributors to communicate the following information to implanting surgeons to avoid the potential of leaving debris in the joint space: 1. Sales representative is to inspect instrumentation before every surgery per the Instructions For Use. A small object should be pushed against the end of the pin to confirm it is securely fixed in place. 2. The sales rep should warn of the possibility of the loose pin and steps to take to confirm containment of the loose pin in order to mitigate patient risk. 3. After use of the instrument, it should be verified that the pin remains fixed in place. Distributors were informed that when devices that meet specification become available for the 5 impacted lots, a field exchange will occur as part of a reportable recall. Distributors are requested to complete the acknowledgment form and return it by 8-10-2020 to confirm that they have read and understood best practices for use of the knee punch handle, and have disseminated the information to all employees and contracted Sales Representatives. Customers with questions should contact Teffany Hutto by phone at (512) 834-6255 or by email at teffany.hutto@djoglobal.com. On 03/12/2021, recall notices were emailed to additional customers informing them of additional affected models/lots.
• Quantity in Commerce: 190 units
• Distribution: U.S. Nationwide distribution including in the states of VA, TN, MN, TX, IL, IN, KY, OH, SC, RI, MD, PA, NY, CA, KS, OK, AR, LA, FL, AL, GA, AZ, NV, WA, MS, ME, NV and Puerto Rico.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MBH