{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "184376", "product_res_number": "Z-0584-2021", "event_date_initiated": "2020-11-19", "event_date_created": "2020-12-15", "recall_status": "Terminated", "event_date_terminated": "2022-07-01", "res_event_number": "86713", "product_code": "HTO", "k_numbers": [ "K013527", "K042899", "K111437", "K993335" ], "product_description": "DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument\nPart Code: 03.404.029S", "code_info": "All Lots UDI: 10886982274038", "firm_fei_number": "3008812560", "recalling_firm": "Synthes (USA) Products LLC", "address_1": "1301 Goshen Pkwy", "city": "West Chester", "state": "PA", "postal_code": "19380-5986", "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", "root_cause_description": "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:\nThis 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. \n\nOpen 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. \nCAUTION:\nIf 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:\no\tEccentric reaming of the far cortex \no\tDamage to the reamer head connection, resulting in metal fragments in the canal\nNOTE: \n\"\tFor 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. \n\"\tFor 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\n\nPlease take the following actions:\n\"\tForward this notice to anyone in your facility that needs to be informed. \n\"\tIf any of the subject product has been forwarded to another facility, contact that facility.\n\"\tKeep a copy of this notice with the subject product.\n\"\tIdentify and discard any current Printed Surgical Technique.\n\"\tTo get the updated version visit our website: https://www.jnjmedicaldevices.com/en-US/product/ria-2-system-reamer-irrigator-aspirator \n\"\tReview, 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.\n\"\tShould you have any inquiries please do not hesitate to contact your sales consultant\n\"\tThis letter", "product_quantity": "531 US; 317 OUS", "distribution_pattern": 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"3021477808", "3010047402", "3016032497", "3015212339", "3014314623", "3007143290", "3010303097" ], "device_name": "Reamer", "medical_specialty_description": "Orthopedic", "regulation_number": "888.4540", "device_class": "1" } } ] }