Confidence and Confidence Plus Kit Spinal Cement System (2017-12-18)
- Starting date:
- December 18, 2017
- Posting date:
- January 8, 2018
- 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-65596
Affected Products
A. Confidence Plus Kit Spinal Cement System
B. Confidence Spinal Cement System
Reason
Depuy Spine is initiating a recall for the removal of specified lots of Confidence Spinal Cement System Kits following reports that the Confidence Cement products were difficult to visualize on X-Ray or could not be visualized on X-Ray. These products may contain incorrect amounts of contrast medium.
Affected products
A. Confidence Plus Kit Spinal Cement System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
2839-10-000
Companies
- Manufacturer
-
Medos International Sarl
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND
B. Confidence Spinal Cement System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
2839-13-000
Companies
- Manufacturer
-
Medos International Sarl
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND