Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
FDA device recall Z-0970-2024 · posted 2024-02-01 · Terminated
Recall details
- Recalling firm
- Vortex Surgical Inc.
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HNR
- Quantity affected
- 800 devices
- Distribution
- Worldwide - US Nationwide distribution in the states of OH, WA, MN, MI, IA and the country of Republic of Korea
- Date initiated
- 2023-12-18
- Date posted
- 2024-02-01
- Date terminated
- 2024-04-04
- Location
- Saint Charles, MO
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