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Howmedica revision instrument system (hris) storage & sterilization case and tray

Official notice

6 Jun 2024

Last checked

6 Jun 2024

Critical riskHealth Canada
Watch Stryker Neurovascular

An official Health Canada notice concerns Howmedica revision instrument system (hris) storage & sterilization case and tray. Gray revision instruments are single-use, sterile-packaged manual surgical instruments intended for one-time use during hip or knee arthroplasty, or trauma surgeries. The HRIS storage & sterilization case and tray part number 6210-9-900 has dedicated locations that include instrument silhouettes and part number markings that are silkscreen printed on the trays for the instruments. This may lead to the re-use and re-sterilization of these single-use sterile-packaged instruments. Recall Start Date: May 23, 2024 Published 2024-06-06.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75629

Official notice

2024-06-06

The hazard

Gray revision instruments are single-use, sterile-packaged manual surgical instruments intended for one-time use during hip or knee arthroplasty, or trauma surgeries. The HRIS storage & sterilization case and tray part number 6210-9-900 has dedicated locations that include instrument silhouettes and part number markings that are silkscreen printed on the trays for the instruments. This may lead to the re-use and re-sterilization of these single-use sterile-packaged instruments. Recall Start Date: May 23, 2024

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

75629

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Affected products

Product 1

Affected products - Howmedica Revision Instrument System (HRIS) Storage & Sterilization Case and Tray, Lot or serial number - All lots., Model or catalog number - 6210-9-900

Risk / hazard

Gray revision instruments are single-use, sterile-packaged manual surgical instruments intended for one-time use during hip or knee arthroplasty, or trauma surgeries. The HRIS storage & sterilization case and tray part number 6210-9-900 has dedicated locations that include instrument silhouettes and part number markings that are silkscreen printed on the trays for the instruments. This may lead to the re-use and re-sterilization of these single-use sterile-packaged instruments. Recall Start Date: May 23, 2024

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Stryker Neurovascular, Howmedica Revision Instrument System Storage Sterilization Case And Tray

Manufacturer

Not provided

Phone

Not provided

Brand: Stryker Neurovascular, Howmedica Revision Instrument System Storage Sterilization Case And Tray.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

critical

Recall details

Recall number

75629

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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