Z-0970-2024 Class II Terminated
FDA device recall Z-0970-2024 was initiated by Vortex Surgical Inc. on December 18, 2023 and is designated Class II. 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 ACTU… The recall status is terminated (terminated April 4, 2024). Affected quantity: 800 devices.
Recall Details
- Product Type
- Devices
- Report Date
- February 7, 2024
- Initiation Date
- December 18, 2023
- Termination Date
- April 4, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 800 devices
Product Description
Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
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 Pattern
Worldwide - US Nationwide distribution in the states of OH, WA, MN, MI, IA and the country of Republic of Korea
Code Information
UDI/DI 00810123481132, Lot Numbers 2212002 and 2212020