Device 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).
Z-0362-2014
Product summary
- Event
- Event 66609
- Status
- Terminated
- Classification
- Class II
- Quantity
- 66 units
- Official record key
device-enforcement:Z-0362-2014
Official wording
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.
Code information: Item Number: A-642100 All Serial Numbers.
Distribution pattern: US Distribution including the states of AL, TX, NY, CA, VA, GA, WI, NC, ID and NJ.
Derived failure modes
-
Unknown
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.