Geistlich Bio-Oss Pen (2019-03-27)

Starting date:

March 27, 2019

Posting date:

April 12, 2019

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-69558

Last updated: 2019-04-12

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  Reason
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  Affected products

Affected Products

Geistlich Bio-Oss Pen

Reason

A user found a green particle on the outside of the applicator after taking off the (green) filter cap. The particle was discovered prior to use. However, in the opinion of the manufacturer and the complaining user, the possibility that such a particle could go undetected and, subsequently, inadvertently implanted is given.

Affected products