Health product recall

Herbst Bite Jumper (2018-06-07)

Starting date:
June 7, 2018
Posting date:
February 15, 2019
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-69028

Affected Products

Herbst Bite Jumper

Reason

Notification from the manufacturer (American Orthodontics) indicates a recent lot of the Herbst Miniscope mechanism packages labeled as Herbst Miniscope, 21mm left, has been identified to potentially contain Herbst Miniscope mechanisms that are actually 18mm in length, but laser marked with 21mm.

Affected products

Herbst Bite Jumper

Lot or serial number

MATER102
MATER98

Model or catalog number

3000-0010

Companies
Manufacturer

Allesee Orthodontic Appliances Inc.

13931 Spring Street

Sturtevant, Wisconsin

53177

UNITED STATES