This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
NOBEL PARALLEL CC GUIDED SURGERY KIT (2016-07-20)
- Starting date:
- July 20, 2016
- Posting date:
- August 10, 2016
- 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-59744
Affected products
A. NOBEL PARALLEL CC GUIDED SURGERY KIT
Reason
Nobel quality management systems have detected that the instructions for use (IFU) and the manual for guided surgery with NobelParallel Conical Connection implants include an incorrect drill protocol for the fully guided surgery using the 4.3 mm implant diameter in soft bone. The IFU and manual are related to the NobelParallel CC Guided Surgery Kit, article #38072. The instructions printed on the kit plate itself, placed at the top of the plate, reference the correct drills for all implant diameters and bone types.
Affected products
A. NOBEL PARALLEL CC GUIDED SURGERY KIT
Lot or serial number
All lots
Model or catalog number
- 38072
Companies
- Manufacturer
-
Nobel Biocare AB
Vastra Hamngatan 1
GOTEBORG
40226
SWEDEN