Ossur North America Inc recalls Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inc

Recalled November 27, 2013 · FDA recall Z-0362-2014 · Ossur North America

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. · FDA Class II

Units

66 units

Sold at

US Distribution including the states of AL, TX, NY, CA, VA, GA, WI, NC, ID and NJ.

Description

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.

Product

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).

Manufacturer(s)

Ossur North America Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →