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Depuy CMW 2 Gentamicin Bone Cement (2014-02-06)
- Starting date:
- February 6, 2014
- Posting date:
- March 20, 2014
- 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-38471
Recalled Products
Depuy CMW 2 Gentamicin Bone Cement
Reason
The unit carton of the label incorrectly states that the amount of gentamicin in the bone cement is 1.0 MIU (million international units). The actual amount of gentamicin in the bone cement is 0.5 MIU the product mas made to specification and the information is correct on the instructions for use (IFU) and the foil pouch. The only incorrect artwork is on the carton label.
Affected products
Depuy CMW 2 Gentamicin Bone Cement
Lot or serial number
3325-020
Model or catalog number
3590475
3607803
3620321
3625505
Companies
- Manufacturer
-
Depuy International Limited T/A Depuy CMW,
Cornford Road,
Blackpool, Lancashire,
FY4 4QQ
UNITED KINGDOM