This page has been archived on the Web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.
Hermes Evolution Knee System - Femoral Stems (2014-08-01)
- Starting date:
- August 1, 2014
- Posting date:
- August 25, 2014
- 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-41165
Recalled Products
Hermes Evolution Knee System - Femoral Stems
Reason
Reference 5037 has a label on the device's packaging and sealing membrane that reads "tibial extension" instead of "femoral extension." The lots for references 5034 and 5044 have matching labels that read "femoral extension," both on the box and on the extra labels provided; however, the label on the sealing membrane reads " tibial extension."
Affected products
Hermes Evolution Knee System - Femoral Stems
Lot or serial number
- 970767/2042
- 970767/3042
- 970779/1471
- 970779/3042
- 970779/3282
- 982699/2042
- 982699/2282
- 982699/3042
- 982699/3282
- 982803/1471
Model or catalog number
- 5034
- 5037
- 5044
Companies
- Manufacturer
-
Ceraver Les Laboratoires Osteal médical
69 Rue de La belle Etoile, CDG Cedex,
Roissy
95957
FRANCE