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Durasul modular head
Official notice
15 Mar 2023
Last checked
15 Mar 2023
An official Health Canada notice concerns Durasul modular head. Zimmer Biomet is conducting a medical device correction to update the compatibility matrix as referred to in the instructions for use (IFU) for the CoCr Femoral Head XS. The update is to remove the compatibility with the Epsilon Durasul Constrained Acetabular liners from the matrix due to the range of motion in flexion/extension being less than 100 degrees as recommended per an internationally recognized standard (ISO 21535:2009). When used in combination with the Epsilon Durasul Constrained Acetabular liner, the CoCr Femoral Head XS has a range of motion of 76 degrees. The reduced range of motion could potentially result in the health risks identified. There have been no complaints for this issue. Recall start date: March 3, 2023 Published 2023-03-15.
What to do now
Contact the manufacturer if you require additional information.
Recall number
73329
Official notice
2023-03-15
The hazard
The hazard
Zimmer Biomet is conducting a medical device correction to update the compatibility matrix as referred to in the instructions for use (IFU) for the CoCr Femoral Head XS. The update is to remove the compatibility with the Epsilon Durasul Constrained Acetabular liners from the matrix due to the range of motion in flexion/extension being less than 100 degrees as recommended per an internationally recognized standard (ISO 21535:2009). When used in combination with the Epsilon Durasul Constrained Acetabular liner, the CoCr Femoral Head XS has a range of motion of 76 degrees. The reduced range of motion could potentially result in the health risks identified. There have been no complaints for this issue. Recall start date: March 3, 2023
How to check if you're affected
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.
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Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected vehicles were sold.
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Company & contacts
Company & contacts
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Brand: Zimmer, Durasul Modular Head.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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