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No image published for this recall

Integra Lifesciences C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System - safety alert

Official notice

18 Dec 2019

Last checked

18 Dec 2019

Medium riskFDA

An official FDA notice concerns Integra Lifesciences C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System - safety alert. An official FDA notice concerns C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System. The notice reports a product safety risk. Follow the official notice for consumer instructions. Published 2019-12-18. Recall numbers: Z-0621-2020. Check the official notice for the complete list. Published 2019-12-18.

What to do now

The source does not provide specific consumer instructions. Follow the official FDA notice for next steps.

Units affected

820

Recall number

Z-0621-2020

Official notice

2019-12-18

The hazard

An official FDA notice concerns C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System. The notice reports a product safety risk. Follow the official notice for consumer instructions. Published 2019-12-18. Recall numbers: Z-0621-2020. Check the official notice for the complete list.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Event Ids

84216

Recall Numbers

Z-0621-2020

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Affected products

Product 1

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Units affected

820

Risk / hazard

An official FDA notice concerns C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System. The notice reports a product safety risk. Follow the official notice for consumer instructions. Published 2019-12-18. Recall numbers: Z-0621-2020. Check the official notice for the complete list.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States · NJ · Plainsboro

Affected area 1

US · United States · NJ · Plainsboro

Affected area 2

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Integra Lifesciences. Contact: Integra LifeSciences Corp..

Source & status

Source

Tier

official

Category

ELECTRONICS

App estimate

medium

Recall details

Recall number

Z-0621-2020

Event id

84216

Units affected

820

Status

terminated

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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