FDA Medical Device Recalls (openFDA)
TEKNIMED SAS: HIGH V+ Spinal Cement System REF T040321K
- Recall number
- Z-1099-2023
- Recalling firm
- TEKNIMED SAS
- Product
- HIGH V+ Spinal Cement System REF T040321K
- Status
- Open, Classified
- Initiated
- 2022-12-15
- Posted
- 2023-02-06
- Terminated
- not on file
- Reason
- Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28.
- Root 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
- 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.
- Lot, serial or model codes
- Model/Part Number: T040321K UDI-DI Code: 03760177043084 Batch Number: 060422382
- 510(k) numbers
- ["K161114"]
- PMA numbers
- not on file
- Product code
- NDN
- Firm FEI
- 3003854593
- Firm city
- L'Union
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28