Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45
FDA device recall Z-0043-2007 · posted 2006-10-19 · Terminated
Recall details
- Recalling firm
- Bioplate Inc
- Reason for recall
- Lack of device sterilization: An internal investigation found products were released for distribution labeled as sterile, but the lot was not sterilized.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JEY
- Quantity affected
- 36 units
- Distribution
- Nationwide to: CA, DC, GA, MI, OH, & PA
- Date initiated
- 2006-09-12
- Date posted
- 2006-10-19
- Date terminated
- 2011-09-14
- Location
- Los Angeles, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THE BIOPLATE RESORBABLE ENDOBROW FIXATION SYSTEM (K051845) | Bioplate, Inc. | 2005-07-27 |