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Terminated

Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25

FDA Recall Z-0970-2024 · Posted 2024-02-01

Recalling FirmVortex Surgical Inc.
Recall StatusTerminated
Product CodeHNR
Date Initiated2023-12-18
Date Terminated2024-04-04
Product Quantity800 devices

Reason for Recall

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Worldwide - US Nationwide distribution in the states of OH, WA, MN, MI, IA and the country of Republic of Korea

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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