FDA recall Z-1099-2023

TEKNIMED SAS · Class II · device

Product

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.

Distribution

Worldwide distribution - U.S. Nationwide distribution in the state of MS and the countries of Poland, Lithuania, Spain, Taiwan, South Africa, Israel.

Key facts

Status
Ongoing
Initiation date
2022-12-15
Report date
2023-02-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
L'Union, France

Primary source

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