Medical device recalls Moderate risk

TEKNIMED SAS recalls HIGH V+ Spinal Cement System REF T040321K

Recall date
December 15, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1099-2023
FDA classification
Class II
Brand / firm
TEKNIMED SAS
Sold / distributed
Worldwide distribution - U.S. Nationwide distribution in the state of MS and the countries of Poland, Lithuania, Spain, Taiwan, South Africa, Israel.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HIGH V+ Spinal Cement System REF T040321K

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