Class 2 Device Recall United Orthopedics USTAR II Knee System

• Date Initiated by Firm: August 27, 2021
• Create Date: October 14, 2021
• Recall Status: Terminated on January 20, 2023
• Recall Number: Z-0110-2022
• Recall Event ID: 88692
• 510(K)Number: K190100
• Product Classification: Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
• Product: United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025
• Code Information: Catalog Number: 2915-1025 UDI Code: 04719872148197 Lot Code: 19E272H
• Recalling Firm/ Manufacturer: Uoc Usa Inc; 15251 Alton Parkway Ste 100; Irvine CA 92618
• For Additional Information Contact: Calvin Lin; 949-328-3366 Ext. 188
• Manufacturer Reason for Recall: Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.
• FDA Determined Cause: Device Design
• Action: On 08/27/2021, the Recalling Firm communicated via email a letter to customers/US surgeons informing them that they are initiating a product recall limited to its 25 mm segment from its knee system due to an out of specification condition that has the potential to pose a risk to patients. Customers are instructed to return unused products. For questions, contact the Director of Customer Service at 949-328-3366 or the Vice President of Marketing at 949-501-8575. On 09/16/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" notification letter to additional customers, who have not used or received any of the affected product, just to make them aware of the recall. The Urgent Medical Device Recall notification identified the reason for the recall, the potential risks associate with the use of the affected product, and instructed these customers that to notify the recalling firm is they have any of the affected products. The Recalling Firm can be contacted via email harsh.gupta@unitedorthopedic.com or via phone at 949-501-8575. On 09/24/2021, the Recalling Firm communicated an updated "URGENT: MEDICAL DEVICE RECALL" Notification Letter informing customers that had received the affected recalled devices, of the recall action and the potential hazards associated with the affected products. In addition, this updated notification was also informing their customers, if they have any patients with the affected product implanted, the Recalling Firm's investigation did not reveal any reason to suggest that there is any imminent danger to the patient since the noted failure was primarily due to a fall from height. It is up to the medical discretion of the treating physicians regarding whether or not to notify the patient. It is also up to the medical discretion of the treating physician whether or not to consider a revision surgery to replace the affected segment. Any questions, contact: -Director of Customer Service at 949-328-3366, or -Vice President of
• Quantity in Commerce: 3 devices
• Distribution: U.S. Nationwide: CA, CO, and NV No O.U.S.
• 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 = KRO