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Infinity resection guide

Official notice

7 Jun 2022

Last checked

7 Jun 2022

Medium riskHealth Canada

An official Health Canada notice concerns Infinity resection guide. Stryker has identified a nonconformance (via product complaint june 2021) relating to the infinity™ resection guide. Specifically, the products were incorrectly color-coded with yellow ink instead of blue ink. The device is designed to be inked with a uniglaze blue color that corresponds to size 4 instrumentation for size 4 implants. Instead, yellow ink was used, and yellow ink corresponds to a different size. Recall start date: May 26, 2022 Published 2022-06-07.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64241

Official notice

2022-06-07

The hazard

Stryker has identified a nonconformance (via product complaint june 2021) relating to the infinity™ resection guide. Specifically, the products were incorrectly color-coded with yellow ink instead of blue ink. The device is designed to be inked with a uniglaze blue color that corresponds to size 4 instrumentation for size 4 implants. Instead, yellow ink was used, and yellow ink corresponds to a different size. Recall start date: May 26, 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

64241

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Affected products

Product 1

Affected products - Infinity Resection Guide, Lot or Serial number - 2039558, Model or Catalogue number - 33620254

Risk / hazard

Stryker has identified a nonconformance (via product complaint june 2021) relating to the infinity™ resection guide. Specifically, the products were incorrectly color-coded with yellow ink instead of blue ink. The device is designed to be inked with a uniglaze blue color that corresponds to size 4 instrumentation for size 4 implants. Instead, yellow ink was used, and yellow ink corresponds to a different size. Recall start date: May 26, 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: Wright Medical Technology, Infinity Resection Guide.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

64241

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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