[Recalled] Durasul Modular Head — Device compatibility - Labelling and packaging | Health Canada 2023-03-15

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

Why it was recalled

According to the Health Canada — Medical Devices notice, the identified hazard is: 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

This recall concerns Orthopaedics products and was recorded by Health Canada — Medical Devices. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Review the official notice to confirm whether your unit is affected.

Read the full official notice →

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.