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Integra Lifesciences - safety alert

Official notice

20 Dec 2023

CriticalFDA

An official FDA notice concerns Integra Lifesciences. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2023-12-20. Recall numbers: Z-0548-2024. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

4,941

Recall number

Z-0548-2024

Official notice

2023-12-20

The hazard

Health risk requiring medical assessment

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.

Other

UDI-DI 10381780520665

Event Ids

93084

Recall Numbers

Z-0548-2024

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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

Affected area 1

US · United States

Affected area 2

AU · Australia

Affected area 3

CA · Canada

Affected area 4

NZ · New Zealand

Company & contacts

Manufacturer

Not provided

Phone

Not provided

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

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class I

App estimate

critical

Recall details

Recall number

Z-0548-2024

Event id

93084

Units affected

4,941

Status

active

Classification

Class I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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