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Titanium Tube Clamp Assembly 400mm (2015-07-27)
- Starting date:
- July 27, 2015
- Posting date:
- October 14, 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-55338
Affected Products
Titanium Tube Clamp Assembly 400mm
Reason
Prosthetic component normally used to connect the prosthetic knee to the prosthetic foot of a prosthesis used by a lower limb amputee consists of a titanium pyramid receiving adapter permanently attached to an aluminum pylon. The pylon was separated from the adapter during fabrication of the prosthesis by two different customers in two different locations.
Affected products
Titanium Tube Clamp Assembly 400mm
Lot or serial number
Not applicable
Model or catalog number
7400
Companies
- Manufacturer
-
ORTHO ACTIVE APPLIANCES LTD
250 SCHOOLHOUSE STREET, SUITE #103
Coquitlam
V3K 6V7
British Columbia
CANADA