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Durasul modular head

Official notice

15 Mar 2023

Last checked

15 Mar 2023

Medium riskHealth Canada
Watch Zimmer

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

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

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

73329

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Affected products

Product 1

Affected products - Durasul Modular Head, Lot or serial number - All lots., Model or catalog number - 01.01012.384

Risk / 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

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Zimmer, Durasul Modular Head

Manufacturer

Not provided

Phone

Not provided

Brand: Zimmer, Durasul Modular Head.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

73329

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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