No image published for this recall

No image published for this recall

Comprehensive shoulder system mini humeral stem, porous plasma, 15 mm, 83 mm long

Official notice

17 Jan 2022

Last checked

17 Jan 2022

Critical riskHealth Canada

An official Health Canada notice concerns Comprehensive shoulder system mini humeral stem, porous plasma, 15 mm, 83 mm long. Zimmer Biomet is conducting a lot specific medical device recall for the comprehensive shoulder system mini humeral stem. The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength, which could potentially lead to the risks identified. Recall start date: Jan 12, 2022 Published 2022-01-17.

What to do now

Contact the manufacturer if you require additional information.

Recall number

63829

Official notice

2022-01-17

The hazard

Zimmer Biomet is conducting a lot specific medical device recall for the comprehensive shoulder system mini humeral stem. The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength, which could potentially lead to the risks identified. Recall start date: Jan 12, 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.

Lots

specific

Recall Numbers

63829

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Affected products

Product 1

Affected products - Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 Mm, 83 Mm Long, Lot or serial number - 396250, Model or catalog number - 113635

Risk / hazard

Zimmer Biomet is conducting a lot specific medical device recall for the comprehensive shoulder system mini humeral stem. The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength, which could potentially lead to the risks identified. Recall start date: Jan 12, 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: Biomet Orthopedics, MINI.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

critical

Recall details

Recall number

63829

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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