Ringloc Bipolar Acetabular Components (2020-09-10)

Starting date:

September 10, 2020

Posting date:

September 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-73931

Last updated:
2020-09-18

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  Reason
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  Affected products

Affected Products

Ringloc Bipolar Acetabular Components

Reason

Zimmer Biomet is conducting a medical device recall for three lots of the Ringloc Bi-polar Hip System Acetabular Cup. The affected lots were gamma sterilized twice. There is not sufficient data to support the functionality, shelf life, or package integrity for more than one-time sterilization.

Affected products