Recall Z-1099-2023 ยท NDN Cement, Bone, Vertebroplasty
TEKNIMED SAS
HIGH V+ Spinal Cement System REF T040321K
| Date | Feb 6, 2023 (initiated Dec 15, 2022) |
| Status | Open, Classified |
| Reason | Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28. |
| Root cause | Employee error |
| 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161114 | HIGH V+ Teknimed Sas, Apr 12, 2017 |