Invisalign System (2019-12-12)
- Starting date:
- December 12, 2019
- Posting date:
- January 7, 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-72047
Last updated: 2020-01-07
Affected products
A. Invisalign
B. Invisalign Teen
C. Invisalign Go
D. Invisalign System - Lite
E. Invisalign First - Moderate
F. Invisalign System - Comprehensive
G. Invisalign System - Moderate
H. Invisalign System - Express
I. Invisalign System Lite
Reason
Doctors received aligner product boxes with enclosed invisalign treatment overview for patients, however the paper instructions for interproximal reduction did not match the correct instructions on the on-line chincheck treatment plan.
Affected products
A. Invisalign
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5217
8048
8500
Companies
- Manufacturer
-
Align Technology INC.
2820 Orchard Parkway
San José
95134
California
UNITED STATES
B. Invisalign Teen
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
8019
Companies
- Manufacturer
-
Align Technology INC.
2820 Orchard Parkway
San José
95134
California
UNITED STATES
C. Invisalign Go
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
8612
Companies
- Manufacturer
-
Align Technology INC.
2820 Orchard Parkway
San José
95134
California
UNITED STATES
D. Invisalign System - Lite
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
8523
Companies
- Manufacturer
-
Align Technology INC.
2820 Orchard Parkway
San José
95134
California
UNITED STATES
E. Invisalign First - Moderate
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
9006
Companies
- Manufacturer
-
Align Technology INC.
2820 Orchard Parkway
San José
95134
California
UNITED STATES
F. Invisalign System - Comprehensive
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
9000
Companies
- Manufacturer
-
Align Technology INC.
2820 Orchard Parkway
San José
95134
California
UNITED STATES
G. Invisalign System - Moderate
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
9001
Companies
- Manufacturer
-
Align Technology INC.
2820 Orchard Parkway
San José
95134
California
UNITED STATES
H. Invisalign System - Express
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
9003
Companies
- Manufacturer
-
Align Technology INC.
2820 Orchard Parkway
San José
95134
California
UNITED STATES
I. Invisalign System Lite
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
9002
Companies
- Manufacturer
-
Align Technology INC.
2820 Orchard Parkway
San José
95134
California
UNITED STATES