Health product recall

Certain Encode 2-PC EP Healing Abutment (2020-01-10)

Starting date:
January 1, 2020
Posting date:
January 24, 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-72179



Last updated: 2020-01-24

Affected Products

Certain Encode 2-PC EP Healing Abutment

Reason

Recall due to device manufactured incorrectly resulting in an incorrect rotation and margin contour alignment of the definitive BellaTek abutment.

Affected products

Certain Encode 2-PC EP Healing Abutment

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

More than 10 numbers, contact manufacturer.

Companies
Manufacturer

BioMet 3I, also trading as Implant Innovations Inc.

4555 RIVERSIDE DRIVE

Palm Beach Gardens

33410

Florida

UNITED STATES