Recall Z-0970-2024 ยท HNR Forceps, Ophthalmic
Vortex Surgical Inc.
Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
| Date | Feb 1, 2024 (initiated Dec 18, 2023) |
| Status | Terminated |
| Reason | Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea. The residue is associated with one lot of forceps tips which were utilized in two lots of ACTU8 Adaptive Forceps Tips occurring in 0.25% of those lots. |
| Root cause | Device Design |
| Action | The firm issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 12/18/2023 via email. The notice explained the problem with the device, risk to health associated with its use, and requested the return of all devices. |
| Quantity | 800 devices |
| Distribution | Worldwide - US Nationwide distribution in the states of OH, WA, MN, MI, IA and the country of Republic of Korea |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.