Health product recall

Durasul Modular Head

Brand(s)
Last updated

Summary

Product
Durasul Modular Head
Issue
Medical devices - Device compatibility
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Durasul Modular Head

All lots.

01.01012.384

Issue

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Orthopaedics
Companies

Zimmer GmbH

Sulzer Allee 8, Winterthur, Switzerland, Switzerland, 8404

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73329

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