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Precice system

Official notice

10 Jan 2022

Last checked

10 Jan 2022

Medium riskHealth Canada

An official Health Canada notice concerns Precice system. NSO is notifying that the products outlined are not indicated for use in individuals under the age of 18 years old. Also, NSO intends to make users aware of the gaps in the biological assessments for these devices as outlined in ISO 10993-1:2018 biological evaluation of medical device. Recall start date: Feb 1, 2021 Published 2022-01-10.

What to do now

Contact the manufacturer if you require additional information.

Recall number

63804

Official notice

2022-01-10

The hazard

NSO is notifying that the products outlined are not indicated for use in individuals under the age of 18 years old. Also, NSO intends to make users aware of the gaps in the biological assessments for these devices as outlined in ISO 10993-1:2018 biological evaluation of medical device. Recall start date: Feb 1, 2021

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.

Recall Numbers

63804

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Affected products

Product 1

Affected Products - Precice System, Lot or serial number - All lots, Model or catalog number - STU1-001

Risk / hazard

NSO is notifying that the products outlined are not indicated for use in individuals under the age of 18 years old. Also, NSO intends to make users aware of the gaps in the biological assessments for these devices as outlined in ISO 10993-1:2018 biological evaluation of medical device. Recall start date: Feb 1, 2021

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Specialized, Precice System.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

63804

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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