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U.S. Department of Health and Human Services

Class 2 Device Recall HIGH V Spinal Cement System

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  Class 2 Device Recall HIGH V Spinal Cement System see related information
Date Initiated by Firm December 15, 2022
Date Posted February 06, 2023
Recall Status1 Open3, 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 2		 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 and Original Applicant = Teknimed, SAS
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