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Integra Lifesciences - safety alert

Official notice

3 Aug 2022

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 2022-08-03. Recall numbers: Z-1395-2022. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

1,210

Recall number

Z-1395-2022

Official notice

2022-08-03

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 10381780533778

Event Ids

90457

Recall Numbers

Z-1395-2022

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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

AE · United Arab Emirates

Affected area 3

AT · Austria

Affected area 4

AU · Australia

Affected area 5

BE · Belgium

Affected area 6

CA · Canada

Affected area 7

CH · Switzerland

Affected area 8

CZ · Czech Republic

Affected area 9

DE · Germany

Affected area 10

DK · Denmark

Affected area 11

EE · Estonia

Affected area 12

ES · Spain

Affected area 13

FI · Finland

Affected area 14

FR · France

Affected area 15

GB · United Kingdom

Affected area 16

GR · Greece

Affected area 17

HK · Hong Kong

Affected area 18

IE · Ireland

Affected area 19

IL · Israel

Affected area 20

IT · Italy

Affected area 21

LT · Lithuania

Affected area 22

LV · Latvia

Affected area 23

NL · Netherlands

Affected area 24

NO · Norway

Affected area 25

NZ · New Zealand

Affected area 26

PK · Pakistan

Affected area 27

PT · Portugal

Affected area 28

SA · Saudi Arabia

Affected area 29

SE · Sweden

Affected area 30

SK · Slovakia

Affected area 31

ZA · South Africa

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-1395-2022

Event id

90457

Units affected

1,210

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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