HIGH V+ Spinal Cement System REF T040321K
FDA Recall Z-1099-2023 · Posted 2023-02-06
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Recalling FirmTEKNIMED SAS
Recall StatusOpen, Classified
Product CodeNDN
Date Initiated2022-12-15
Product Quantity236 systems
Reason for Recall
Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28.
Firm Action
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
Root Cause
Employee error
Distribution Pattern
Worldwide distribution - U.S. Nationwide distribution in the state of MS and the countries of Poland, Lithuania, Spain, Taiwan, South Africa, Israel.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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