Z-0362-2014 Class II Terminated
FDA device recall Z-0362-2014 was initiated by Ossur North America Inc on October 24, 2013 and is designated Class II. 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. The recall status is terminated (terminated June 17, 2014). Affected quantity: 66 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 27, 2013
- Initiation Date
- October 24, 2013
- Termination Date
- June 17, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 66 units
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.
Distribution Pattern
US Distribution including the states of AL, TX, NY, CA, VA, GA, WI, NC, ID and NJ.
Code Information
Item Number: A-642100 All Serial Numbers.