Class 2 Device Recall EMPOWR Partial Knee

• Date Initiated by Firm: June 19, 2020
• Create Date: November 20, 2020
• Recall Status: Open, Classified
• Recall Number: Z-0480-2021
• Recall Event ID: 85943
• 510(K)Number: K191325
• Product Classification: Prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer - Product Code HSX
• Product: EMPOWR Partial Knee Peg Drill; Model: 800-06-008.
• Code Information: all lot numbers
• Recalling Firm/ Manufacturer: Encore Medical, LP; 9800 Metric Blvd; Austin TX 78758-5445
• For Additional Information Contact: Teffany Hutto; 512-834-6200
• Manufacturer Reason for Recall: There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The extended length of the drill guide and tight tolerances to ensure accurate preparation seem to be contributing to this situation. There is a potential of a delay in surgery if this issue were to recur.
• FDA Determined Cause: Other
• Action: The method of notification was via e-mail to surgical sales agents, and the notices were issued on 06/18/2020. Additionally, a notification to return the affected drills for replacement were sent via e-mail to affected surgical agents on 07/20/20. The following recommendations should be communicated to the implanting surgeons: Sales Agents Action: To avoid the potential binding, the following is recommended: " Use a plunge mill approach, i.e. plunge the drill in and out of the drill guide bushing a few times slowly until the hole is fully prepared. " Use of saline or fat to keep the drill lubricated during use. " Inspect all instrumentation prior to use to identify any wear, breakage or damage. Along with the notification, the communication includes an acknowledgment form that should be completed and returned to confirm that the instructions provided have been read and understood. THE ACKNOWLEDGEMENT SHOULD BE REVIEWED AND COMPLETED BY JULY 6, 2020.For questions, contact Teffany Hutto by phone at (512) 834-6255 or by email at teffany.hutto@djoglobal.com.
• Quantity in Commerce: 28 units
• Distribution: US: AZ, CA, FL, GA, IL, IN, MI, MN, NY, TX, VA, and WA.. No OUS Consignees.
• 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 = HSX