"Market withdrawal" means a firm's removal or correction of a distributed product which involves a minor violation for which FDA would not initiate legal action, or which involves no violation (e.g., normal stock rotation practices, routine equipment adjustments and repairs, product improvement, etc.) Replacement of device components which fail (wear out) after a reasonable life span will be considered a market withdrawal unless a violation of the FD&C Act has occurred and can be supported (e.g., failure to conduct adequate finished product outsourcing, or sample analysis reveals a defective product.)