Class 2 Device Recall Collared Cementless Hip Stem

• Date Initiated by Firm: July 12, 2017
• Date Posted: February 12, 2018
• Recall Status: Terminated on May 20, 2019
• Recall Number: Z-0593-2018
• Recall Event ID: 79024
• Product Classification: Prosthesis, hip, hemi-, femoral, metal - Product Code KWL
• Product: CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9
• Code Information: Part No. 3L93709 and Lot No. 5291990
• Recalling Firm/ Manufacturer: DePuy Orthopaedics, Inc.; 700 Orthopaedic Dr; Warsaw IN 46582-3994
• For Additional Information Contact: 574-267-8143
• Manufacturer 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).
• FDA Determined Cause: 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. Note: The affected devices may be on consignment at your facility. Return 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. Reconciliation 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 Records: Retain a copy of the completed Reconciliation Form in your files along with this notice. Additional Notifications: Notify surgeon users at your facility by providing them with a copy of this notice to ensure surgeon users are aware of this recall. Forward this notice to others in your facility that need to be informed. If any affected product has been forwarded to another facility, contact that facility immediately to communicate this field action with the facility/facilities. Maintain a copy of this notice with the affected devices. Contacts For 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. For 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. Health 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
• Quantity in Commerce: 21 Units
• Distribution: 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.
• 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.