FDA-Device2013-11-27Class II
Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the tube horizontally in relation to other components. It is fully compatible with all standard 30mm prosthetic pylons. (3) Offset: 14,5mm (0.57inch).
Ossur North America Inc
Hazard
Ossur inititated a voluntary recall of the A-642100 Fixed Offset Adapter because it can develop fatigue cracks in normal use over an extended period of time and ultimately separate completely.
Sold states
US Distribution including the states of AL, TX, NY, CA, VA, GA, WI, NC, ID and NJ.
Affected count
66 units
Manufactured in
27051 Towne Centre Dr, Foothill Ranch, CA, United States
Products
Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the tube horizontally in relation to other components. It is fully compatible with all standard 30mm prosthetic pylons. (3) Offset: 14,5mm (0.57inch).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0362-2014Don't want to check this manually?
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