Z-0575-03

Nobel Biocare Replace Select Radiographic Template, part number 30159

Name: Z-0575-03 Nobel Biocare Replace Select Radiographic Template, part number 30159
Creator: Nobel Biocare USA Inc
Published: 2003-01-27
License: https://open.fda.gov/license/

Nobel Biocare USA LLC / initiated 2003-01-27 / Terminated / root cause: labeling and UDI

FDA source

Nobel Biocare USA Inc began a recall of Nobel Biocare Replace Select Radiographic Template, part number 30159 on 2003-01-27. The reason FDA records is "Misprinted radiographic template plates. Misprinted labeling". 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-0575-03
Status: Terminated
Initiated: 2003-01-27
Posted: 2003-02-25
Terminated: 2003-08-21
Recalling firm: Nobel Biocare USA LLC
Product: Nobel Biocare Replace Select Radiographic Template, part number 30159.
Reason for recall: Misprinted radiographic template plates. Misprinted labeling.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The firm''s recall notice asks customers to return the template that the customer has in a prepaid envelope for a replacement. The firm is also placing a notice on it''s web based order page so customers can be reminded when ordering.
Quantity in commerce: Not stated. Irrelevant to recall strategy.
Distribution: Nationwide and internationally to Andorra, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, England, Finland, France, Germany, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Luxemburg, Malyasia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Russia, San Marino, Sardina, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Virgin Islands.
Product codes and lots: No codes apply. All physicians need to ensure the template is replaced.

K964220Class IIReplace Titanium Implant SystemSteri-Oss, Inc. / cleared 1997-03-05

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)