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Tornier AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101 - safety alert

Official notice

5 Jul 2023

Last checked

5 Jul 2023

Medium riskFDA

An official FDA notice concerns Tornier AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101 - safety alert. An official FDA notice concerns AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2023-07-05. Recall numbers: Z-2019-2023. Check the official notice for the complete list. Published 2023-07-05.

What to do now

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

Units affected

55

Recall number

Z-2019-2023

Official notice

2023-07-05

The hazard

An official FDA notice concerns AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2023-07-05. Recall numbers: Z-2019-2023. 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

92520

Recall Numbers

Z-2019-2023

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Affected products

Product 1

AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101

Units affected

55

Risk / hazard

An official FDA notice concerns AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2023-07-05. Recall numbers: Z-2019-2023. 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

US · United States · MN · Bloomington

Affected area 1

US · United States · MN · Bloomington

Affected area 2

US · United States

Company & contacts

Brand

Manufacturer

Not provided

Phone

Not provided

Brand: Tornier. Contact: Tornier, Inc.

Source & status

Source

Tier

official

Category

ELECTRONICS

App estimate

medium

Recall details

Recall number

Z-2019-2023

Event id

92520

Units affected

55

Status

active

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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