HIGH V+ Spinal Cement System REF T040321K
FDA Recall #Z-1099-2023 — Class II — December 15, 2022
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.
Recalling Firm
TEKNIMED SAS — L'Union
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
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.
Code Information
Model/Part Number: T040321K UDI-DI Code: 03760177043084 Batch Number: 060422382
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated