Vanguard Knee System PS Tibial Bearing 11 mm 63/67 mm (2018-05-16)

Starting date:

May 16, 2018

Posting date:

June 6, 2018

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-66984

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  Reason
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  Affected products

Affected products

Vanguard Knee System PS Tibial Bearing 11 mm 63/67 mm

Reason

Zimmer Biomet is conducting a medical device recall due to a labeling error for specific lots of the Vanguard Knee System. The label master file was errantly set up as a 63/37mm instead of 63/67mm. There is no 63/37 size offered and the product is laser marked with the correct size, 63/67.

Affected products