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Aroa Biosurgery OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G - safety alert

Official notice

21 Nov 2018

Last checked

21 Nov 2018

Medium riskFDA

An official FDA notice concerns Aroa Biosurgery OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G - safety alert. An official FDA notice concerns OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G. The notice reports a product safety risk. Follow the official notice for consumer instructions. Published 2018-11-21. Recall numbers: Z-0420-2019. Check the official notice for the complete list. Published 2018-11-21.

What to do now

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

Units affected

881

Recall number

Z-0420-2019

Official notice

2018-11-21

The hazard

An official FDA notice concerns OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G. The notice reports a product safety risk. Follow the official notice for consumer instructions. Published 2018-11-21. Recall numbers: Z-0420-2019. 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

81166

Recall Numbers

Z-0420-2019

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Affected products

Product 1

OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G

Units affected

881

Risk / hazard

An official FDA notice concerns OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G. The notice reports a product safety risk. Follow the official notice for consumer instructions. Published 2018-11-21. Recall numbers: Z-0420-2019. 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

NZ · New Zealand · Lower Hutt

Affected area 1

NZ · New Zealand · Lower Hutt

Affected area 2

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Aroa Biosurgery. Contact: AROA Biosurgery, LTD..

Source & status

Source

Tier

official

Category

ELECTRONICS

App estimate

medium

Recall details

Recall number

Z-0420-2019

Event id

81166

Units affected

881

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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