No image published for this recall

No image published for this recall

Grafton and grafton plus demineralized bone matrix

Official notice

1 Mar 2023

Last checked

1 Mar 2023

Medium riskHealth Canada

An official Health Canada notice concerns Grafton and grafton plus demineralized bone matrix. Medtronic is voluntarily recalling specific serial numbers of Grafton™ DMB due to the potential for breach in the sterile barrier. All lots manufactured before November 30 2022 are impacted. Recall start date: February 15, 2023 Published 2023-03-01.

What to do now

Contact the manufacturer if you require additional information.

Recall number

73004

Official notice

2023-03-01

The hazard

Medtronic is voluntarily recalling specific serial numbers of Grafton™ DMB due to the potential for breach in the sterile barrier. All lots manufactured before November 30 2022 are impacted. Recall start date: February 15, 2023

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

73004

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Affected products

Product 1

Affected products - Grafton Plus Demineralized Bone Matrix (Dbm), Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - S45010 S45001 S45005

Product 2

Affected products - Grafton Demineralized Bone Matrix (Dbm), Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - S42090 S43101 S43102 S43105 S43103 S44115 S44150 S42200 S42210 S42275 S44135 S41120 S41150 S43110 S44125 S42280 S44105 S44145

Risk / hazard

Medtronic is voluntarily recalling specific serial numbers of Grafton™ DMB due to the potential for breach in the sterile barrier. All lots manufactured before November 30 2022 are impacted. Recall start date: February 15, 2023

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

Brand: Medtronic Sofamor Danek, Grafton And Grafton Plus Demineralized Bone Matrix.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

73004

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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