Drill Extension for Astra Tech Implant System (2019-04-07)
- Starting date:
- April 7, 2019
- Posting date:
- April 29, 2019
- 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-69750
Last updated: 2019-04-30
Affected Products
Drill Extension for Astra Tech Implant System
Reason
We received a complaint from an internal sales representative about 7 out of 10 drill extensions having a reduced or missing clamping functionality:
Tool malfunction: sales representative announced drill extensions with fitting problems during a course event. Issue was found before use of product - no patient involved.
Affected products
Drill Extension for Astra Tech Implant System
Lot or serial number
- 417849
- 419645
Model or catalog number
22520
Companies
- Manufacturer
-
DENTSPLY Implants Manufacturing GmbH
Steinzeugstr. 50
Mannheim
GERMANY