Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch)

FDA device recall Z-0362-2014 · posted 2013-11-19 · Terminated

Recall details

Recalling firm

Ossur North America Inc

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

ISH

Quantity affected

66 units

Distribution

US Distribution including the states of AL, TX, NY, CA, VA, GA, WI, NC, ID and NJ.

Date initiated

2013-10-24

Date posted

2013-11-19

Date terminated

2014-06-17

Location

Foothill Ranch, CA