Recall Z-1099-2023
Teknimed SAS · initiated December 15, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
HIGH V+ Spinal Cement System REF T040321K
Codes / lots: Model/Part Number: T040321K UDI-DI Code: 03760177043084 Batch Number: 060422382
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 taken
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
Details
- Recall number
- Z-1099-2023
- Initiated
- December 15, 2022
- Posted by FDA
- February 6, 2023
- Product code
- NDN – Cement, Bone, Vertebroplasty
- Quantity
- 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.
- Recalling firm
- Teknimed SAS, L'Union