PRODUCT

Model 250 NeuroCybernetic Prostheses (NCP) Programming Software Versions

a) 4/1;

b) 4.4, implanted autonomic nerve stimulator for he treatment of
epilepsy.

REASON

The label insert sheets were printed with the incorrect lot number.

CODE

Lot numbers a) 23952C; b) 26023C, 27137C, 27735C.

Recall #Z-570/571-0.

MANFACTURER

Cyberonics, Inc., Inc., Houston, Texas.

RECALLED BY

Manufacturer, by telephone and letter on August October 6, 1999. Firm-
initiated field correction complete.

DISTRIBUTION

a) Canada; b) Belgium and Europe.

QUANTITY

a) 1 unit of lot number 23952C; b) 10 units of lot number, 26023C, 10
units of lot 27137C and 50 units of lot 27735C were distributed.