Summary
The FDA issued a Class II for Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25 by Vortex Surgical Inc.. 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 fo.
Details
Source
Device Recall
External ID
Z-0970-2024
Action Date
2024-02-07
Status
Terminated
Category
device
Product Description
Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
Lot/Code Info: UDI/DI 00810123481132, Lot Numbers 2212002 and 2212020
Quantity Affected: 800 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.
Distribution
Worldwide - US Nationwide distribution in the states of OH, WA, MN, MI, IA and the country of Republic of Korea
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-18
Company
Saint Charles, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 221 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Vortex Surgical Inc. has 16 FDA actions in our database, including 15 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Vortex Surgical Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Vortex Surgical Inc. have FDA actions?
Vortex Surgical Inc. has 16 FDA actions in our database, including 15 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0970-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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