Recall Z-0465-2022 ยท GXZ Electrode, Needle
Technomed Europe
Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
| Date | Dec 8, 2021 |
| Status | Terminated |
| Reason | There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp. |
| Root cause | Device Design |
| Action | The firm distributed an Urgent Medical Device Recall notice dated 12/07/2021 to customers in the United States via email on 12/08/2021. In this notice the firm identifies affected product as being recalled due to the high risk of the needle electrode and lead wire coming loose from the hub, resulting in potential medical intervention to remove the inserted needle electrode, including removal using forceps or incision. The recalling firm requested that customers notify any recipients of recalled product down the distribution chain by forwarding a copy of the notice, that the customer be aware t |
| Quantity | 117,672 devices |
| Distribution | US Nationwide distribution in the states of California, Florida, and Ohio. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130136 | DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES, Technomed Europe, Jul 19, 2013 |