| Date Initiated by Firm | December 18, 2023 |
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| Date Posted | February 01, 2024 |
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| Recall Status1 |
Terminated 3 on April 04, 2024 |
| Recall Number | Z-0970-2024 |
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| Recall Event ID |
93725 |
| Product Classification |
Forceps, ophthalmic - Product Code HNR
|
| Product | Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25 |
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| Code Information |
UDI/DI 00810123481132, Lot Numbers 2212002 and 2212020 |
Recalling Firm/
Manufacturer |
Vortex Surgical Inc.
4 Research Park Dr Ste 124
Saint Charles MO 63304-5639
|
| For Additional Information Contact |
636-778-4350 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Device Design |
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| Action | 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. |
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| Quantity in Commerce | 800 devices |
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| Distribution | Worldwide - US Nationwide distribution in the states of OH, WA, MN, MI, IA and the country of Republic of Korea |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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