Health product recall

Invisalign System (2019-08-12)

Starting date:
August 12, 2019
Posting date:
September 6, 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-70899

Last updated: 2019-09-06

Affected Products

A. Invisalign
B. Invisalign System - Comprehensive

Reason

Recall due to potential incorrect shipment and labeling of devices.

Affected products

A. Invisalign

Lot or serial number

25751945

Model or catalog number

8500

Companies
Manufacturer

Align Technology INC.

2820 Orchard Parkway

San José

95134

California

UNITED STATES

B. Invisalign System - Comprehensive

Lot or serial number

29643551
29727907
29833285

Model or catalog number

9000

Companies
Manufacturer

Align Technology INC.

2820 Orchard Parkway

San José

95134

California

UNITED STATES