HIGH V+ Spinal Cement System REF T040321K
FDA device recall Z-1099-2023 · posted 2023-02-06 · Open, Classified
Recall details
- Recalling firm
- TEKNIMED SAS
- Reason for recall
- Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28.
- Action taken
- 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 quality@tekmimed.com 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
- Status
- Open, Classified
- Product code
- NDN
- Quantity affected
- 236 systems
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the state of MS and the countries of Poland, Lithuania, Spain, Taiwan, South Africa, Israel.
- Date initiated
- 2022-12-15
- Date posted
- 2023-02-06
- Location
- L'Union, France
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HIGH V+ (K161114) | Teknimed Sas | 2017-04-12 |