Class 2 Device Recall HIGH V Spinal Cement System

• Date Initiated by Firm: December 15, 2022
• Date Posted: February 06, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1099-2023
• Recall Event ID: 91493
• 510(K)Number: K161114
• Product Classification: Cement, bone, vertebroplasty - Product Code NDN
• Product: HIGH V+ Spinal Cement System REF T040321K
• Code Information: Model/Part Number: T040321K UDI-DI Code: 03760177043084 Batch Number: 060422382
• Recalling Firm/ Manufacturer: TEKNIMED SAS; Zone Industrielle Montredone; 11 Rue D Apollo; L'Union France
• For Additional Information Contact: M. Franck DRUILHET; 512 388 0199
• Manufacturer Reason for Recall: Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28.
• FDA Determined Cause: Employee error
• Action: On 12/15/2022, the firm contacted customer via a "URGENT - FIELD SAFETY NOTICE" informing them of the incorrect expiry date of 2027-02-28 and that the correct expiration date is 2025-02-28. Customers are instructed to: 1. Notify all within their organization or to any organizations where the devices have been transferred. 2. Isolate the concerned products in their facilities and/or in their customers' ones. 3. Complete and return by email, within 7 calendar days, the attached statement for the product return, by indicating the concerned quantity by lot and by company to TEKNIMED SAS, Quality Department quality@tekmimed.com 4. Return, all products clearly identified as recalled products and with the attached statement at the following address: Quality Department TEKNIMED SAS, Z.I. de la Herray, 65500 VIC en BIGORRE (France). For questions or assistance - contact Quality Manager at +33 5 34 25 10 60
• Quantity in Commerce: 236 systems
• Distribution: Worldwide distribution - U.S. Nationwide distribution in the state of MS and the countries of Poland, Lithuania, Spain, Taiwan, South Africa, Israel.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NDN