CONSERVE BIOFOAM CUP and CONSERVE PLUS SHELL AND THIN SHELL (2016-06-22)

Starting date:

June 22, 2016

Posting date:

July 19, 2016

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-59404

• Reason
• Affected products

Affected products

1. CONSERVE PLUS THIN SHELL
2. CONSERVE PLUS SHELL
3. CONSERVE BIOFOAM CUP

Reason

Investigation of the metal on metal THA systems shows an increasing overall trend in revisions from 2009 to present, and it was found that there were a specific hazard/harm for suspected tissues reaction to metal debris. The potential for a patient reaction when implanted with metal on metal is a known risk.

Affected products