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Recall Observatory FDA recall evidence

Device product

HIGH V+ Spinal Cement System REF T040321K

Z-1099-2023

December 15, 2022

Class II

Product summary

Firm
TEKNIMED SAS
Event
Event 91493
Status
Ongoing
Classification
Class II
Quantity
236 systems
Official record key
device-enforcement:Z-1099-2023

Official wording

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

Code information: Model/Part Number: T040321K UDI-DI Code: 03760177043084 Batch Number: 060422382

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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