Optipac Refobacin Bone Cement R (2019-12-20)

Starting date:

December 20, 2019

Posting date:

January 10, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72073

Last updated: 2020-01-10

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  Reason
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  Affected products

Affected Products

Optipac Refobacin Bone Cement R

Reason

Biomet France Sarl and Biomet Orthopedics Switzerland GmbO are conducting jointly a field safety corrective action for certain optiPac products. Some color variations (different shade of green) of the sterile dot were reported through product complaints. To date, no adverse events have been reported. By means of this field safety notice, Zimmer Biomet would like to inform the users that color variations in the sterile dots do not imply the product's sterility is affected, and that the products can continue to be used within their sterility date. This field safety notice does not require return of

any products.

Affected products