Spinal Cement System Recalled for Incorrect Expiration Date
TEKNIMED SAS is recalling HIGH V+ Spinal Cement System (236 units) due to mislabeling showing expiration date of February 28, 2027 instead of the correct date February 28, 2025.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for incorrect expiration date labeling on surgical spinal cement. The mislabeled date is two years later than actual expiration, creating risk of harm through use of expired medical device in surgical procedures, with no reported illnesses or injuries to date.
Plain-English summary
TEKNIMED SAS is recalling 236 units of the HIGH V+ Spinal Cement System (Model/Part Number T040321K, UDI-DI Code 03760177043084, Batch Number 060422382) due to incorrect expiration date labeling.
The product is labeled with an expiration date of February 28, 2027, but the correct expiration date is February 28, 2025. This labeling error creates a risk that the product could be used beyond its intended expiration date.
The recalled product was distributed worldwide, including the United States (Mississippi) and internationally to Poland, Lithuania, Spain, Taiwan, South Africa, and Israel.
Healthcare facilities and providers should immediately identify any affected product using the batch number and contact TEKNIMED SAS. Patients who have received this product should consult their healthcare provider.
The recalled product
- Product
- HIGH V+ Spinal Cement System REF T040321K
- Manufacturer
- TEKNIMED SAS
- Category
- Medical Device — Spinal Cement
- Hazard
- Affected units
- 236
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model/Part Number: T040321K UDI-DI Code: 03760177043084 Batch Number: 060422382
Distribution
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