FDAFDA · Food and drugs·Recall number Z-0362-2014
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).
Published November 27, 2013 · Recall initiated: October 24, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ossur North America Inc
- Distributor
- US Distribution including the states of AL, TX, NY, CA, VA, GA, WI, NC, ID and NJ.
- Lot
- Item Number: A-642100 All Serial Numbers.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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