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Scorpio and duracon total knee systems
Official notice
21 Dec 2023
Last checked
21 Dec 2023
An official Health Canada notice concerns Scorpio and duracon total knee systems. The industry guidance for storage duration of Ultra High Molecular Weight Polyethylene (UHMWPE) raw material used in the manufacture of soft implant bearing/articulating material of prosthetic joints is less than 5 years. Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. Stryker has become aware that the devices listed in the product/lot number attachment PFA 3306872 section of the customer letter have been manufactured with UHMWPE raw material aged over 5 years. Recall Start Date: December 5, 2023 Published 2023-12-21.
What to do now
Contact the manufacturer if you require additional information.
Recall number
74779
Official notice
2023-12-21
The hazard
The hazard
The industry guidance for storage duration of Ultra High Molecular Weight Polyethylene (UHMWPE) raw material used in the manufacture of soft implant bearing/articulating material of prosthetic joints is less than 5 years. Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. Stryker has become aware that the devices listed in the product/lot number attachment PFA 3306872 section of the customer letter have been manufactured with UHMWPE raw material aged over 5 years. Recall Start Date: December 5, 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.
Recall Numbers
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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.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Howmedica Osteonics, Scorpio And Duracon Total Knee.
Source & status
Source & status
Source
Tier
Category
Classification
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Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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