Nobel Biocare USA Inc
Nobel Biocare Replace Select Radiographic Template, part number 30159.
| Date | Feb 25, 2003 (initiated Jan 27, 2003) |
| Status | Terminated |
| Reason | Misprinted radiographic template plates. Misprinted labeling. |
| 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 | 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, Ru |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964220 | REPLACE TITANIUM IMPLANT SYSTEM Steri-Oss, Inc., Mar 5, 1997 |