Z-1099-2023Class II

HIGH V+ Spinal Cement System REF T040321K

Name: Z-1099-2023 HIGH V+ Spinal Cement System REF T040321K
Creator: Teknimed Sas
Published: 2022-12-15
License: https://open.fda.gov/license/

Teknimed SAS / initiated 2022-12-15 / Open, Classified / root cause: manufacturing process

FDA source

TEKNIMED SAS began a recall of HIGH V+ Spinal Cement System REF T040321K on 2022-12-15. FDA classified it as Class II and gives the reason as "Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1099-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-15
Posted: 2023-02-06
Recalling firm: Teknimed SAS
Product: HIGH V+ Spinal Cement System REF T040321K
Product code: NDN Cement, Bone, Vertebroplasty
Reason for recall: Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28.
Root cause tag: manufacturing process
FDA 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 [email protected] 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.
Product codes and lots: Model/Part Number: T040321K UDI-DI Code: 03760177043084 Batch Number: 060422382

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1099-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1099-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-06

Product code NDN

K161114Class IIHigh V+Teknimed Sas / cleared 2017-04-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)