Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
This recall has been terminated (originally issued February 1, 2024).
- Company
- Vortex Surgical Inc.
- Recall Initiated
- December 18, 2023
- Posted
- February 1, 2024
- Terminated
- April 4, 2024
- Recall Number
- Z-0970-2024
- Quantity
- 800 devices
- Firm Location
- Saint Charles, MO
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide - US Nationwide distribution in the states of OH, WA, MN, MI, IA and the country of Republic of Korea
Lot / Code Info
UDI/DI 00810123481132, Lot Numbers 2212002 and 2212020
Root Cause
Device Design
Action Taken
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.