Recall Z-1823-2020 · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
U&I CORP.
Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disk disease at one level from C2-C3 disc to the C7-T1 disc. Each product is composed of four components: PEEK cage, titanium plate, and two titaniu
| Date | Jan 30, 2019 |
| Status | Terminated |
| Reason | The vertical dimensions of screw-hole position in some standalone cages might be out of range in engineering drawings. A possibility exists of screw pullout, lossening, instability, or less bone-screw engagement than intended by physicians. |
| Root cause | Employee error |
| Action | On 01/30/2019, "Notification for Sales Suspension and Product recall" and explanation of nonconformity notices were emailed to the domestic customer. The notification requests customers identify, isolate and return affected products immediately. It requests acknowledgement, and quantity of devices to be returned. The contact number for further questions is +82 31 860-6830 or kkjane@youic.com |
| Quantity | 42 |
| Distribution | US Nationwide distribution in the state of CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172424 | Velofix SA Cervical Cage U&I Corporation, Nov 22, 2017 |