This page has been archived on the Web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.
Standard Offset Cup Impactor
- Starting date:
- October 7, 2016
- Posting date:
- November 18, 2016
- 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-61150
Reason
Greatbatch reports that recent sterilization testing performed in a dedicated instrument case revealed that the device did not meet an acceptable sterility assurance level using the sterilization parameters identified in instructions for use (IFU) manual MAN-000002 Revision D. The location of the failure was under the POM-C (blue) handle.
Affected products
Standard Offset Cup Impactor
Lot or serial number
All lots
Model or catalog number
T6318
Companies
- Manufacturer
-
Greatbatch Medical
10000 Wehrle Drive
Clarence
14031
New York
UNITED STATES