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Navitracker kit a : knee

Official notice

24 Jan 2022

Last checked

24 Jan 2022

Critical riskHealth Canada

An official Health Canada notice concerns Navitracker kit a : knee. Zimmer Biomet is conducting a medical device recall for one lot of the Navitracker Kit A : Knee product, which is a nonpatient contacting device used during computer and robotic assisted surgeries. The product in scope was released for distribution without passing sterilization results. This could potentially lead to insufficient sterility of the product, which may lead to the risks identified. Recall start date: Jan 13, 2022 Published 2022-01-24.

What to do now

Contact the manufacturer if you require additional information.

Recall number

63858

Official notice

2022-01-24

The hazard

Zimmer Biomet is conducting a medical device recall for one lot of the Navitracker Kit A : Knee product, which is a nonpatient contacting device used during computer and robotic assisted surgeries. The product in scope was released for distribution without passing sterilization results. This could potentially lead to insufficient sterility of the product, which may lead to the risks identified. Recall start date: Jan 13, 2022

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

63858

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Affected products

Product 1

Affected Products - Navitracker Kit A : Knee, Lot or serial number - 110221A1, Model or catalog number - 20-8000-000-07

Risk / hazard

Zimmer Biomet is conducting a medical device recall for one lot of the Navitracker Kit A : Knee product, which is a nonpatient contacting device used during computer and robotic assisted surgeries. The product in scope was released for distribution without passing sterilization results. This could potentially lead to insufficient sterility of the product, which may lead to the risks identified. Recall start date: Jan 13, 2022

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: Orthosoft Ulc Dba Zimmer Cas, Navitracker Kit A Knee.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

critical

Recall details

Recall number

63858

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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