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Hermes Evolution Knee System - various components (2015-02-09)
- Starting date:
- February 9, 2015
- Posting date:
- March 27, 2015
- 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-52685
Recalled Products
A. Hermes posterior stabilized knee
B. Hermes Evolution Knee System
C. Hermes Evolution PS tibial plateau
Reason
During the blister packaging of these devices in the clean room, before they went off for sterilization, a partial inversion occurred between parts of a lot of Size 4, Thickness 9, Hermes PS tibial plateaux and a lot of Size 5, Thickness 9, Hermes PS tibial plateaux. Size 5 plateaux are in the packages with labels referring to Size 4 plateaux.
Affected products
A. Hermes posterior stabilized knee
Lot or serial number
113057
Model or catalog number
1215
Companies
- Manufacturer
-
Ceraver Les Laboratoires Osteal médical
69 Rue de La belle Etoile, CDG Cedex,
Roissy
95957
FRANCE
B. Hermes Evolution Knee System
Lot or serial number
113057
Model or catalog number
1215
Companies
- Manufacturer
-
Ceraver Les Laboratoires Osteal médical
69 Rue de La belle Etoile, CDG Cedex,
Roissy
95957
FRANCE
C. Hermes Evolution PS tibial plateau
Lot or serial number
113057
Model or catalog number
1215
Companies
- Manufacturer
-
Ceraver Les Laboratoires Osteal médical
69 Rue de La belle Etoile, CDG Cedex,
Roissy
95957
FRANCE