Class 2 Device Recall Confidence Plus Kit Spinal Cement System

• Date Initiated by Firm: December 15, 2017
• Create Date: April 03, 2018
• Recall Status: Terminated on April 13, 2020
• Recall Number: Z-1300-2018
• Recall Event ID: 79494
• 510(K)Number: K060300
• Product Classification: Cement, bone, vertebroplasty - Product Code NDN
• Product: Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630); ; The CONFIDENCE SPINAL CEMENT SYSTEM¿ 11cc Kit is intended for percutaneous delivery of CONFIDENCE 11cc Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).
• Code Information: Lot numbers: 129385 129386 133824 133825 133826 133827 133828 133829 133830 133831 134609 134610 134611 134612 134613 134614 135476 135477 135478 145664 145665 145666 145667 145668 145669 145670 145671 147555 152905 152906 152908 153880 153881 153882 153883 153884 153885 153886 153888 153889 154956 154957 HVKBHH HVKBHJ
• Recalling Firm/ Manufacturer: DePuy Spine, Inc.; 325 Paramount Dr; Raynham MA 02767-5199
• For Additional Information Contact: Christina Corbett; 508-977-2619
• Manufacturer Reason for Recall: Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the product is difficult or impossible to visualize on x-ray.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm, DePuy Synthes, sent an "URGENT FIELD SAFETY NOTIFICATION-RECALL CONFIDENCE KIT SPINAL CEMENT SYSTEM" dated 12/2017 to its consignees. The notification described the product, problem and actions to be taken. Notifications were sent to consignees with the following instructions: 1. Immediately identify and quarantine all unused products listed below in a manner that ensures the affected products will not be used. 2. Review, complete, sign and return the attached Business Reply Form to your local DePuy Synthes sales organization in accordance with the directions on the form within 5 business days of receipt of this notification. 3. Return any affected product within 30 business days. A credit note will be issued for the returned items. 4. Forward this notice to anyone in your facility that needs to be informed. 5. If any impacted products have been forwarded to another facility, contact that facility and provide them with this letter. 6. Maintain awareness of this notice until all products listed below have been returned to DePuy Spine. 7. Keep a copy of this notice. If you have questions about this Field Safety Notification, please contact your DePuy Synthes Spine Sales Consultant or the Recall Coordinator via telephone: 1-508-828-6609 or via email: DPYUS-SpineFieldActions@its.jnj.com).
• Quantity in Commerce: 1972
• Distribution: International Distribution (outside the U.S.) only: Mexico, Canada, Ireland, Great Britain, Malaysia, Germany, Austria, Colombia, Spain, Austria, Switzerland, Australia, Hungary, Croatia, and Sweden.
• 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 = NDN and Original Applicant = DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.