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Infinity occipitocervical upper thoracic system multi axial screw
Official notice
1 Mar 2023
Last checked
1 Mar 2023
An official Health Canada notice concerns Infinity occipitocervical upper thoracic system multi axial screw. It was identified by Medtronic that an incorrect type of titanium was used for the manufacturing of subcomponents of multi-axial screws that are for use as part of the Infinity oct system. This incorrect material reduces the clamping strength of the multi-axial screw, which may lead to a loss of fixation with the infinity system construct. Recall start date: February 16, 2023 Published 2023-03-01.
What to do now
Contact the manufacturer if you require additional information.
Recall number
73005
Official notice
2023-03-01
The hazard
The hazard
It was identified by Medtronic that an incorrect type of titanium was used for the manufacturing of subcomponents of multi-axial screws that are for use as part of the Infinity oct system. This incorrect material reduces the clamping strength of the multi-axial screw, which may lead to a loss of fixation with the infinity system construct. Recall start date: February 16, 2023
How to check if you're affected
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.
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Affected products
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Affected area 1
Company & contacts
Company & contacts
Manufacturer
Phone
Brand: Medtronic Sofamor Danek, Infinity Occipitocervical Upper Thoracic System Multi Axial Screw.
Source & status
Source & status
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Tier
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Classification
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Recall details
Recall details
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Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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