Alpen Clinic 100 Carbide & Alpen SteriX (2020-10-16)
- Starting date:
- October 16, 2020
- Posting date:
- November 6, 2020
- 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-74253
Last updated:
2020-11-04
Affected Products
- Alpen Clinic 100 Carbide
- Alpen SteriX
Reason
The incorrect dental Carbide Bur was manufactured and subsequently packaged and distributed. The FG 557 Bur was manufactured and then packaged as the FG 57 Bur.
Affected products
A. Alpen Clinic 100 Carbide
Lot or serial number
J75023
Model or catalog number
R100057C
Companies
- Manufacturer
-
Coltene/Whaledent, Inc.
235 Ascot Parkway
Cuyahoga Falls
44223
Ohio
UNITED STATES
B. Alpen SteriX
Lot or serial number
- J75024
- J96954
Model or catalog number
RS100057
Companies
- Manufacturer
-
Coltene/Whaledent, Inc.
235 Ascot Parkway
Cuyahoga Falls
44223
Ohio
UNITED STATES