RETRACTOR

Description of Event or Problem

IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING AN IMPLANT PROCEDURE, WHEN THE RETRACTOR WAS DETERMINED TO BE WET. THE RETRACTOR WAS DISPOSED, AND A NEW RETRACTOR WAS USED. MORE COMPONENTS OF THE LOANER KIT AND ACCESSORY KIT WERE WET, AS WELL. THE PHYSICIAN CHOSE TO USE THE ITEMS THAT DID NOT SHOW THE INTEGRITY OF THE PACKAGING WAS AFFECTED. DISCLAIMER STATEMENT: THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).