Recall Z-0970-2024— Vortex Surgical Inc.
Class II · Terminated
Class II FDA medical device recall by Vortex Surgical Inc., initiated 2023-12-18, terminated 2024-04-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25. 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..
- Recalling firm
- Vortex Surgical Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2023-12-18
- Terminated
- 2024-04-04
- Firm location
- Saint Charles, MO, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.