Veritcal Mandibular Angle %u2122 & Temporal Shell %u2122 Implant and Composite %u2122 EPTFE-Coated Extended Anatomical Chin (2020-10-22)
- Starting date:
- October 22, 2020
- Posting date:
- February 12, 2021
- 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-74983
Last updated:
2021-02-12
Affected Products
A. Vertical Mandibular Angle (TM)-Mandibular Implant-Size: 7, Left
B. Vertical Mandibular Angle (TM)-Mandibular Implant-Size: 7, Right
C. Vertical Mandibular Angle (TM) Sizers
D. Temporal Shell (TM) Implant-Size: 7mm, Left
E. Temporal Shell (TM) Implant-Size: 7mm, Right
F. Composite(TM) EPTFE-Coated Extended Anatomical Chin-Size: Small
Reason
Device was shipped to Canada without appropriate market clearance.
Affected products
A. Vertical Mandibular Angle (TM)-Mandibular Implant-Size: 7, Left
Lot or serial number
886835
Model or catalog number
VMA-7L
Companies
- Manufacturer
-
IMPLANTECH ASSOCIATES, INC. (ALLIED BIOMEDICAL)
6025 NICOLLE ST., SUITE B
VENTURA,
93003
California
UNITED STATES
B. Vertical Mandibular Angle (TM)-Mandibular Implant-Size: 7, Right
Lot or serial number
886441
Model or catalog number
VMA-7R
Companies
- Manufacturer
-
IMPLANTECH ASSOCIATES, INC. (ALLIED BIOMEDICAL)
6025 NICOLLE ST., SUITE B
VENTURA,
93003
California
UNITED STATES
C. Vertical Mandibular Angle (TM) Sizers
Lot or serial number
882810
Model or catalog number
VMA-SIZ-NS
Companies
- Manufacturer
-
IMPLANTECH ASSOCIATES, INC. (ALLIED BIOMEDICAL)
6025 NICOLLE ST., SUITE B
VENTURA,
93003
California
UNITED STATES
D. Temporal Shell (TM) Implant-Size: 7mm, Left
Lot or serial number
885147
Model or catalog number
TS-07L
Companies
- Manufacturer
-
IMPLANTECH ASSOCIATES, INC. (ALLIED BIOMEDICAL)
6025 NICOLLE ST., SUITE B
VENTURA,
93003
California
UNITED STATES
E. Temporal Shell (TM) Implant-Size: 7mm, Right
Lot or serial number
883066
Model or catalog number
TS-07R
Companies
- Manufacturer
-
IMPLANTECH ASSOCIATES, INC. (ALLIED BIOMEDICAL)
6025 NICOLLE ST., SUITE B
VENTURA,
93003
California
UNITED STATES
F. Composite(TM) EPTFE-Coated Extended Anatomical Chin-Size: Small
Lot or serial number
EPTFE-EAC-S
Model or catalog number
EPTFE-EAC-S
Companies
- Manufacturer
-
IMPLANTECH ASSOCIATES, INC. (ALLIED BIOMEDICAL)
6025 NICOLLE ST., SUITE B
VENTURA,
93003
California
UNITED STATES