Recall Z-0362-2014 ยท ISH Component, External, Limb, Ankle/Foot
Ossur North America Inc
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) Off
| Date | Nov 19, 2013 (initiated Oct 24, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | Ossur sent an "Safety Notice Voluntary Product Recall" letter dated October 29, 2013, via regular mail. Follow-up telephones are also made. The letter identified the product the problem and the actions to be taken by the customer. ssur is committed to providing superior customer service and we will do our utmost to minimize any inconvenience this may cause your practice. To ensure patient safety we kindly ask you to take the following action: " Please identify the users of each of the A-642100 adapters, see attached list. " Also, please check your inventory for any A-642100s you may have on |
| Quantity | 66 units |
| Distribution | US Distribution including the states of AL, TX, NY, CA, VA, GA, WI, NC, ID and NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.