Recall Z-0362-2014— Ossur North America Inc
Class II · Terminated
Class II FDA medical device recall by Ossur North America Inc, initiated 2013-10-24, terminated 2014-06-17. FDA's recall record names no specific 510(k) clearance for this event. 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).. Reason: 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..
- Recalling firm
- Ossur North America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-10-24
- Terminated
- 2014-06-17
- Firm location
- Foothill Ranch, CA, United States
Product description
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).
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.