Class 2 Device Recall ATTUNE Revision LPS Insert

• Date Initiated by Firm: February 15, 2023
• Date Posted: March 17, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1265-2023
• Recall Event ID: 91752
• 510(K)Number: K191779
• Product Classification: Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
• Product: Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
• Code Information: GTIN: 10603295491033; Lot: JP9022
• Recalling Firm/ Manufacturer: DePuy Orthopaedics, Inc.; 700 Orthopaedic Dr; Warsaw IN 46582-3994
• For Additional Information Contact: DePuy Synthes Sales Consultant.; 574-267-8143
• Manufacturer Reason for Recall: The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
• FDA Determined Cause: Labeling Change Control
• Action: An URGENT MEDICAL DEVICE RECALL (REMOVAL) notification letter dated 2/14/23 was delivered to customers. Please Take the Following Steps: 1. Examine your inventory immediately to determine if you have the subject products and quarantine the subject products. DO NOT USE THE SUBJECT PRODUCTS. 2. Contact your DePuy Synthes Sales Consultant to coordinate the return/credits of the subject products. 3. Review, complete, sign, and return the attached Business Response Form (See page 3 of this communication) to OneMD-Field-Actions@its.jnj.com within three (3) business days of receipt of this notification. Please include FA 2220700 Attune Inserts in the e-mail subject line. ¿ IMPORTANT: Please complete the attached Business Response Form even if you do not have any units of the subject product on hand. 4. Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the subject products). 5. If any of the subject product has been forwarded to another facility, contact that facility, and provide them with a copy of this notice. 6. Post a copy of this notice in a visible area for awareness and keep a copy for your records. 7. As with any medical device, adverse reactions or quality problems experienced with the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program: " Online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda Health care providers who have treated patients using the products subject to this removal should continue to follow those patients pursuant to the health care provider s standard of care and may consider more frequent follow-up depending on the activity level and needs of an individual patient. For questions, or to consult with an in-house DePuy Synthes physician on this issue, please submit a Medical Information Request via our website: https://www.jnjmedicaldevices.com/mi
• Quantity in Commerce: 7 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand
• 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 = KRO and Original Applicant = Depuy (Ireland)