Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45

Lack of device sterilization: An internal investigation found products were released for distribution labeled as sterile, but the lot was not sterilized.

Customers were notified via telephone initially on 09/14/2006 to return product, and this was followed up within two days with a certified mail/return receipt required, recall notification letter. 100% of the consignees will be notified of the recall. Bioplate will fax and call non-responsive customers afler 5 days via telephone call. Customers not responding to the first recall notification will be sent a second notification certified mail recall notification.