Z-0043-2007

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

Name: Z-0043-2007 Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45
Creator: Bioplate Inc
Published: 2006-09-12
License: https://open.fda.gov/license/

Bioplate Inc / initiated 2006-09-12 / Terminated / root cause: labeling and UDI

FDA source

Bioplate Inc began a recall of Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45 on 2006-09-12. The reason FDA records is "Lack of device sterilization: An internal investigation found products were released for distribution labeled as sterile, but the lot was not sterilized". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0043-2007
Status: Terminated
Initiated: 2006-09-12
Posted: 2006-10-19
Terminated: 2011-09-14
Recalling firm: Bioplate Inc
Product: Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45
Product code: JEY Plate, Bone
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 36 units
Distribution: Nationwide to: CA, DC, GA, MI, OH, & PA
Product codes and lots: Lot number: S29640905

Product code JEY

K051845Class IIThe Bioplate Resorbable Endobrow Fixation SystemBioplate, Inc. / cleared 2005-07-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)