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U.S. Department of Health and Human Services

Class 2 Device Recall Fixed Offset Adapter, A642100

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  Class 2 Device Recall Fixed Offset Adapter, A642100 see related information
Date Initiated by Firm October 24, 2013
Date Posted November 19, 2013
Recall Status1 Terminated 3 on June 17, 2014
Recall Number Z-0362-2014
Recall Event ID 66609
Product Classification Component, external, limb, ankle/foot - Product Code ISH
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).
Code Information Item Number: A-642100    All Serial Numbers. 
Recalling Firm/
Manufacturer		 Ossur North America Inc
27051 Towne Centre Dr
Foothill Ranch CA 92610-2804
For Additional Information Contact
949-360-3634
Manufacturer 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.
FDA Determined
Cause 2		 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 hand but have not fitted on users. A follow-up phone call will be made a few days later to coordinate replacements. A new replacement component will be provided to the customer. For further questions please call (949) 360-3634.
Quantity in Commerce 66 units
Distribution US Distribution including the states of AL, TX, NY, CA, VA, GA, WI, NC, ID and NJ.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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