{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "161203", "product_res_number": "Z-0594-2018", "event_date_initiated": "2017-07-12", "event_date_posted": "2018-02-12", "recall_status": "Terminated", "event_date_terminated": "2019-05-20", "res_event_number": "79024", "product_code": "KWL", "product_description": "CORAIL HIGH OFFSET STEM Collarless SIZE 14", "code_info": "Part No. L20314 and Lot No. 5292130", "firm_fei_number": "1818910", "recalling_firm": "DePuy Orthopaedics, Inc.", "address_1": "700 Orthopaedic Dr", "city": "Warsaw", "state": "IN", "postal_code": "46582-3994", "additional_info_contact": "574-267-8143", "reason_for_recall": "Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), contained the CORAIL HIGH OFFSET STEM Collarless SIZE 14 (Part No. L20314 / Lot No. 5292130).", "root_cause_description": "Mixed-up of materials/components", "action": "In August of 2017 customers were notified via an Urgent Medical Device Recall Letter, titled \"ONE LOT OF CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 and ONE LOT OF CORAIL HIGH OFFSET STEM Collarless SIZE 14\" with instructions to cease using the affected product immediately.\nNote: The affected devices may be on consignment at your facility.\nReturn Affected Implants: Determine if any of the recalled devices are still on hand and return the affected device(s) immediately to the DePuy Sales Consultant or return to DePuy Synthes for credit following the normal returns procedures. \nReconciliation Form: Complete the Reconciliation Form and return to your DePuy Orthopaedics Sales Consultant or fax to 574-371-4939 or scan and email to DPYUS-JointReconFieldActions@its.jnj.co\nRecords: Retain a copy of the completed Reconciliation Form in your files along with this notice.\nAdditional Notifications:\nNotify surgeon users at your facility by providing them with a copy of this notice to ensure surgeon users are aware of this recall.\nForward this notice to others in your facility that need to be informed.\nIf any affected product has been forwarded to another facility, contact that facility immediately to communicate this field action with the facility/facilities.\nMaintain a copy of this notice with the affected devices.\n\nContacts \nFor product-related questions, please contact your local DePuy Orthopaedics, Inc. Sales Consultant. For clinical questions from surgeons, please contact DePuy Orthopaedics, Inc.s Scientific and Medical Affairs mailbox RA-DPYUS-DePSynSc@ITS.JNJ.com. \n\nFor questions about device recall information provided, please contact Kim (Earle) Long, Senior Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. 5 p.m. EDT) or at DPYUS-JointReconFieldActions@its.jnj.com.\n\nHealth care professionals may report serious adverse events, side effects or product quality problems with the use of this product to DePuy Orthopaedics, Inc. either by contacting yo", "product_quantity": "19", "distribution_pattern": "Nationally; US Consignees for this recall are the affected are US Distributors and US Medical Facilities (Hospitals/User Facilities) that may have purchased, used, or received the affected device.", "openfda": { "k_number": [ "K905349", "K943778", "K954534", "K172906", "K063791", "K920193", "K934353", "K924379", "K262290", "K844818", "K823051", "K926120", "K920231", "K922146", "K031841", "K811738", 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"3000196378", "3007740680" ], "device_name": "Prosthesis, Hip, Hemi-, Femoral, Metal", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3360", "device_class": "2" } } ] }