This page has been archived on the Web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.
Versys Hip Cemented Revision / Calcar (2013-09-24)
- Starting date:
- September 24, 2013
- Posting date:
- October 28, 2013
- 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-36455
Recalled Products
Versys Hip Cemented Revision / Calcar
Reason
Zimmer is initiating a lot specific recall of the Versys Hip system cemented revision / Calcar femoral stem due to insufficient sample availability for testing necessary to ensure sterile barrier integrity with the established statistical confidence.
Affected products
Versys Hip Cemented Revision / Calcar
Lot or serial number
More than 100 numbers, contact manufacturer
Model or catalog number
More than 10 numbers, contact manufacturer
Companies
- Manufacturer
-
Zimmer Inc.
1800 West Center Street
Warsaw
46580
Indiana
UNITED STATES