CLASS II ONGOING Device recall · Reported 15 Feb 2023 · FDA Enforcement Report
HIGH V+ Spinal Cement System recalled by Teknimed Sas
Teknimed Sas is recalling HIGH V+ Spinal Cement System, distributed nationwide in the US. The recall was initiated on 15 Dec 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1099-2023
- FDA event ID
- 91493
- Recalling firm
- Teknimed Sas, L'Union
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Dec 2022
- FDA classified
- 6 Feb 2023
- Reported
- 15 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 15 Dec 2022 | Recall initiated by company | |
| 6 Feb 2023 | Classified by FDA | +53 days |
| 15 Feb 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28.
Product as listed by the FDA
HIGH V+ Spinal Cement System REF T040321K
Where it was distributed
Worldwide distribution - U.S. Nationwide distribution in the state of MS and the countries of Poland, Lithuania, Spain, Taiwan, South Africa, Israel.
Questions about this recall
Is HIGH V+ Spinal Cement System recalled?
Yes. Teknimed Sas recalled HIGH V+ Spinal Cement System on 15 Dec 2022. The recall is Class II and its status is Ongoing. Recall number Z-1099-2023.
Why was it recalled?
Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28.
Which lots are affected?
Model/Part Number: T040321K UDI-DI Code: 03760177043084 Batch Number: 060422382
Where was it sold?
Worldwide distribution - U.S. Nationwide distribution in the state of MS and the countries of Poland, Lithuania, Spain, Taiwan, South Africa, Israel.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Spinal Implants recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |