Recall Z-1200-2021 ยท MIJ Needle, Tumor Localization
Somatex Medical Technologies GMBH
Thread-like wire marker
| Date | Feb 3, 2021 |
| Status | Terminated |
| Reason | This recall has been initiated due to the risk of wire splintering after contact with a cautery device during the removal of a lesion. There is a potential risk that wire fragments are not removed during the procedure and stays inside the patient's body. |
| Root cause | Device Design |
| Action | On 1/22/2021, Somatex issued an Urgent Medical Device Removal notice to customers via e-mail for Tuflex and Tuflex Premium marking wires. This recall has been initiated due to the risk of wire splintering after contact with a cautery device during the removal of a lesion. |
| Quantity | 196 pieces |
| Distribution | Domestic: Mo, NJ, OH |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.