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Health product recall

HTR*PMI CORRIVEAU LEFT AND RIGHT FRONTAL PARIETAL TEMPORAL IMPLANT (2016-06-20)

Starting date:
June 20, 2016
Posting date:
July 7, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Hospitals, Healthcare Professionals
Identification number:
RA-59248

Affected products

A. HTR*PMI CORRIVEAU LEFT AND RIGHT FRONTAL PARIETAL TEMPORAL IMPLANT

Reason

Biomet microfixation initiated this field action after the identification of two small voids within the seal of the sterile packaging. These voids may compromise the sterility of the implant, therefore leading to a risk of infection.

Affected products

A. HTR*PMI CORRIVEAU LEFT AND RIGHT FRONTAL PARIETAL TEMPORAL IMPLANT

Lot or serial number

M685300

M685310

 

Model or catalog number

PMXXXXXX

Companies
Manufacturer

Biomet Microfixation, Inc.

1520 TRADEPORT DRIVE,

JACKSONVILLE,

32218

Florida

UNITED STATES