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RE-FLEX ROTATE AND ADAPTERS (2015-07-10)
- Starting date:
- July 10, 2015
- Posting date:
- September 24, 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-54992
Affected Products
A. Re-Flex Rotate
B. Talux
C. Vari-Flex
D. Vari-Flex XC
E. Re-Flex Shock
F. Flex-Foot Assure
G. Balance Foot J
Reason
Recent findings suggest that non-ossur female mating adapters connected to ossur ankle male pyramids have caused early failure of the male pyramid connector. This is due to incompatible geometry of the female mating adaptors used and/or improper set up of the prosthesis.
Affected products
A. Re-Flex Rotate
Lot or serial number
N/A
Model or catalog number
>30, CONTACT MFG
Companies
- Manufacturer
-
Ossur HF
Grjothals 5
Reykjavik
110
ICELAND
B. Talux
Lot or serial number
N/A
Model or catalog number
>10, CONTACT MFG
Companies
- Manufacturer
-
Ossur HF
Grjothals 5
Reykjavik
110
ICELAND
C. Vari-Flex
Lot or serial number
N/A
Model or catalog number
>10, CONTACT MFG
Companies
- Manufacturer
-
Ossur HF
Grjothals 5
Reykjavik
110
ICELAND
D. Vari-Flex XC
Lot or serial number
N/A
Model or catalog number
>10, CONTACT MFG
Companies
- Manufacturer
-
Ossur HF
Grjothals 5
Reykjavik
110
ICELAND
E. Re-Flex Shock
Lot or serial number
N/A
Model or catalog number
>10, CONTACT MFG
Companies
- Manufacturer
-
Ossur HF
Grjothals 5
Reykjavik
110
ICELAND
F. Flex-Foot Assure
Lot or serial number
N/A
Model or catalog number
>10, CONTACT MFG
Companies
- Manufacturer
-
Ossur HF
Grjothals 5
Reykjavik
110
ICELAND
G. Balance Foot J
Lot or serial number
N/A
Model or catalog number
>10, CONTACT MFG
Companies
- Manufacturer
-
Ossur HF
Grjothals 5
Reykjavik
110
ICELAND