FDA-Device2023-02-15Class II

HIGH V+ Spinal Cement System REF T040321K

TEKNIMED SAS
Hazard

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

Sold states
Worldwide distribution - U.S. Nationwide distribution in the state of MS and the countries of Poland, Lithuania, Spain, Taiwan, South Africa, Israel.
Affected count
236 systems
Manufactured in
Zone Industrielle Montredone, 11 Rue D Apollo, L'Union, France
Products
HIGH V+ Spinal Cement System REF T040321K

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1099-2023

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