Recall Z-1099-2023— TEKNIMED SAS

Name: FDA recall Z-1099-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-15

Class II · Ongoing

Class II FDA medical device recall by TEKNIMED SAS, initiated 2022-12-15. It names one FDA 510(k) clearance: K161114. Product: HIGH V+ Spinal Cement System REF T040321K. Reason: Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28..

Recalling firm: TEKNIMED SAS
Classification: Class II
Status: Ongoing
Initiated: 2022-12-15
Firm location: L'Union, France

510(k) clearances named in this recall

1 on FDA's record

K161114 — HIGH V+Teknimed Sas·cleared 2017-04-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

HIGH V+ Spinal Cement System REF T040321K

Reason for recall

Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28.

Data sourced from openFDA. This site is unofficial and independent of the FDA.