HIGH V+ Spinal Cement System REF T040321K recallZ-1099-2023 · Teknimed Sas · initiated Dec 15, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Teknimed Sas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28.
FDA root cause category: Employee error
What the company is doing
On 12/15/2022, the firm contacted customer via a "URGENT - FIELD SAFETY NOTICE" informing them of the incorrect expiry date of 2027-02-28 and that the correct expiration date is 2025-02-28. Customers are instructed to: 1. Notify all within their organization or to any organizations where the devices have been transferred. 2. Isolate the concerned products in their facilities and/or in their customers' ones. 3. Complete and return by email, within 7 calendar days, the attached statement for the product return, by indicating the concerned quantity by lot and by company to TEKNIMED SAS, Quality Department [email protected] 4. Return, all products clearly identified as recalled products and with the attached statement at the following address: Quality Department TEKNIMED SAS, Z.I. de la Herray, 65500 VIC en BIGORRE (France). For questions or assistance - contact Quality Manager at +33 5 34 25 10 60
Recall details
- Recall number
- Z-1099-2023
- Status
- Open, Classified
- Initiated by the company
- Dec 15, 2022
- Posted by the FDA
- Feb 6, 2023
- Recalling firm
- Teknimed Sas
- Quantity
- 236 systems
- Product code
- NDN
- FDA submissions
- K161114
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the state of MS and the countries of Poland, Lithuania, Spain, Taiwan, South Africa, Israel.
Product description
HIGH V+ Spinal Cement System REF T040321K
Code information (models, lots, serial numbers)
Model/Part Number: T040321K UDI-DI Code: 03760177043084 Batch Number: 060422382
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HIGH V+ SPINAL CEMENT SYSTEM T040321KTeknimed · Cement, Bone, Vertebroplasty1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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