Class 2 Device Recall DePuy Synthes

• Date Initiated by Firm: November 19, 2020
• Create Date: December 15, 2020
• Recall Status: Terminated on July 01, 2022
• Recall Number: Z-0573-2021
• Recall Event ID: 86713
• 510(K)Number: K013527 K042899 K111437 K993335
• Product Classification: Reamer - Product Code HTO
• Product: DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.018S
• Code Information: All Lots UDI: 10886982273963
• Recalling Firm/ Manufacturer: Synthes (USA) Products LLC; 1301 Goshen Pkwy; West Chester PA 19380-5986
• Manufacturer Reason for Recall: RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed
• FDA Determined Cause: Use error
• Action: DePuy Synthes issued voluntary device correction letter on 11/19/202 via 2-day by Fed Ex, stating reason for recall, health risk and action to take: This safety notification is advising physicians of the following supplemental information regarding the surgical approach of standard IM nail reaming as referred to in the surgical technique guide. Open the medullary canal and conduct reaming by following AO reaming techniques for IM nailing and maintain a guide wire entry angle of less than 10 from the axis of the canal. CAUTION: If the guide wire entry angle is greater than 10 from the axis of the canal, there is a risk that bowing of the reaming rod will result in: o Eccentric reaming of the far cortex o Damage to the reamer head connection, resulting in metal fragments in the canal NOTE: " For an antegrade femoral approach, if possible, adduct the limb/hip to facilitate access to entry point. For greater trochanter entry point, target >2cm distal to the lesser trochanter1. " For an antegrade tibial approach, the knee will need to be flexed to 90-110 for entry site access. Insert the guide wire aiming down the tibial crest, and thus the center of the medullary canal Please take the following actions: " Forward this notice to anyone in your facility that needs to be informed. " If any of the subject product has been forwarded to another facility, contact that facility. " Keep a copy of this notice with the subject product. " Identify and discard any current Printed Surgical Technique. " To get the updated version visit our website: https://www.jnjmedicaldevices.com/en-US/product/ria-2-system-reamer-irrigator-aspirator " Review, complete, sign, and return the attached reply form on page 4 of this letter to your local sales organization in accordance with the directions on the form within 5-business days of receipt of this notification. " Should you have any inquiries please do not hesitate to contact your sales consultant " This letter
• Quantity in Commerce: 1275 US and 445 OUS
• Distribution: Nationwide Foreign:countries: United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Germany, Spain, United Kingdom, Ireland, Israel, Italy, Singapore,
• 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 = HTO; 510(K)s with Product Code = HTO