Class 2 Device Recall Aesculap

• Date Initiated by Firm: March 19, 2021
• Create Date: September 22, 2021
• Recall Status: Completed
• Recall Number: Z-2515-2021
• Recall Event ID: 88325
• 510(K)Number: K081293 K131167
• Product Classification: Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer - Product Code HRY
• Product: Univation X System knee implant devices as follows:; Catalog/Product:; NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM;; NO181Z AS UNIVATION XF FEMUR CEMENTED F2 RM;; NO182Z AS UNIVATION XF FEMUR CEMENTED F3 RM;; NO183Z AS UNIVATION XF FEMUR CEMENTED F4 RM;; NO184Z AS UNIVATION XF FEMUR CEMENTED F5 RM;; NO185Z AS UNIVATION XF FEMUR CEMENTED F1 LM;; NO186Z AS UNIVATION XF FEMUR CEMENTED F2 LM;; NO187Z AS UNIVATION XF FEMUR CEMENTED F3 LM;; NO188Z AS UNIVATION XF FEMUR CEMENTED F4 LM;; NO189Z AS UNIVATION XF FEMUR CEMENTED F5 LM
• Code Information: All lots
• Recalling Firm/ Manufacturer: Aesculap Implant Systems LLC; 3773 Corporate Pkwy; Center Valley PA 18034-8217
• For Additional Information Contact: SAME; 800-258-1946
• Manufacturer Reason for Recall: Malfunction- loosening of the implant resulting in a potential revision surgery
• FDA Determined Cause: Unknown/Undetermined by firm
• Action: Aesulap issued An Urgent Medical Device Recall via USPS overnight to consignees on March 19, 2021. Letter states reason for recall, health risk and action to take: Immediately examine your inventory, identify and quarantine product related to this notification. In addition, if you have further distributed this product, please identify your customers and notify them at once of this Recall Notification. Your notification to your customers may be enhanced by including a copy of this notification letter. A representative of Aesculap will reach out to you to assist in the return of affected product. 1. Review the univation¿ X Knee System Recall Notification in its entirety and ensure that all users in your organization and other concerned persons are informed about this notification. 2. Active customers with inventory at their site were previously instructed (December 29, 2020 univation¿ X Knee System Field Safety Notification via certified mail) to hold and do not use this product. We are requesting at this time that the product be returned. 3. Action is required of you to sign and return the provided Acknowledgement Response Form identifying (if applicable) the amount of product to the email address listed below before April 16, 2021. If the acknowledgement form has not been received at this time, another Recall Notification Letter will be sent. (Attachment 1 Medical Device Recall Notification Form). Send To: qa-recalls@aesculapusa.com 4. Identify your current inventory for the affected product. a. If you have identified inventory in your facility, DO NOT DESTROY any affected product. Contact Customer Service (info noted below) for an RGR number and return label to return your affected product. AIS Customer Service Number 1-866-229-3002 SetWorld_orders.BBMUS_Service@aesculapimplants.com b. Once the RGR and return paperwork is provided, return a copy along with your affected product to the address listed below. Aesculap Implant Systems SET WORLD HFPU71821 QC Recalls
• Distribution: US Nationwide distribution.
• 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.

• 510(K) Database: 510(K)s with Product Code = HRY and Original Applicant = AESCULAP IMPLANT SYSTEMS, INC.; 510(K)s with Product Code = HRY and Original Applicant = AESCULAP IMPLANT SYSTEMS, LLC