Oxford Partial Knee System Fixed Lateral Tibial Construct, Right-Cemented, E3 (2020-12-02)

Starting date:

December 2, 2020

Posting date:

December 18, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-74567

Last updated:
2020-12-18

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  Reason
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  Affected products

Affected Products

Oxford Partial Knee System Fixed Lateral Tibial Construct, Right-Cemented, E3

Reason

Zimmer Biomet is conducting a lot specific medical device recall for multiple sterile Zimmer Biomet products due to the potential for a breach in the sterile seal. A breach in the packaging seal could potentially lead to loss of sterility of the device. Based on an inspection of the affected packaging, a breach in the sterile seal is estimated to occur in less than 0.5% of the affected product.

Affected products