Summary
The FDA issued a Class II for HIGH V+ Spinal Cement System REF T040321K by TEKNIMED SAS. Reason: Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28..
Details
Source
Device Recall
External ID
Z-1099-2023
Action Date
2023-02-15
Status
Ongoing
Category
device
Product Description
HIGH V+ Spinal Cement System REF T040321K
Lot/Code Info: Model/Part Number: T040321K UDI-DI Code: 03760177043084 Batch Number: 060422382
Quantity Affected: 236 systems
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-15
Company
L'Union
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 163 device recalls issued in the same week, part of 403 device-related FDA actions this month.
TEKNIMED SAS has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (TEKNIMED SAS) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does TEKNIMED SAS have FDA actions?
TEKNIMED SAS has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1099-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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