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Attune™ affixium™ knee system tibial base

Official notice

22 Mar 2024

Last checked

22 Mar 2024

Medium riskHealth Canada

An official Health Canada notice concerns Attune™ affixium™ knee system tibial base. Depuy Ireland Uc has initiated a medical device recall (removal) of one lot of the ATTUNE™ Cementless FB Tibial Base due to incorrect labeling. 3 complaints were received for incorrect labeling associated with the subject product including incorrect inner patient label (inner patient label was for a size 8, carton and product were both size 6), as well as the outer carton labeled as size 6 but contained a size 8 affixium tibial base. No adverse events have been reported. Recall start date: March 13, 2024 Published 2024-03-22.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75285

Official notice

2024-03-22

The hazard

Depuy Ireland Uc has initiated a medical device recall (removal) of one lot of the ATTUNE™ Cementless FB Tibial Base due to incorrect labeling. 3 complaints were received for incorrect labeling associated with the subject product including incorrect inner patient label (inner patient label was for a size 8, carton and product were both size 6), as well as the outer carton labeled as size 6 but contained a size 8 affixium tibial base. No adverse events have been reported. Recall start date: March 13, 2024

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

75285

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Affected products

Product 1

Affected products - ATTUNE™ AFFIXIUM™ Knee System Tibial Base, Lot or serial number - JA06A0252, Model or catalog number - 1506-21-006

Risk / hazard

Depuy Ireland Uc has initiated a medical device recall (removal) of one lot of the ATTUNE™ Cementless FB Tibial Base due to incorrect labeling. 3 complaints were received for incorrect labeling associated with the subject product including incorrect inner patient label (inner patient label was for a size 8, carton and product were both size 6), as well as the outer carton labeled as size 6 but contained a size 8 affixium tibial base. No adverse events have been reported. Recall start date: March 13, 2024

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: Depuy Ireland Uc, Attune™ Affixium™ Knee System Tibial Base.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

75285

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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