Recall Z-0043-2007 ยท JEY Plate, Bone
Bioplate Inc
Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45
| Date | Oct 19, 2006 (initiated Sep 12, 2006) |
| Status | Terminated |
| Reason | Lack of device sterilization: An internal investigation found products were released for distribution labeled as sterile, but the lot was not sterilized. |
| Root cause | Other |
| Action | 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. |
| Quantity | 36 units |
| Distribution | Nationwide to: CA, DC, GA, MI, OH, & PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051845 | THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM Bioplate, Inc., Jul 27, 2005 |