Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Nobel Biocare Replace Select Radiographic Template, part number 30159.

FDA Recall Z-0575-03 · Posted 2003-02-25

Recalling FirmNobel Biocare USA Inc
Recall StatusTerminated
Date Initiated2003-01-27
Date Terminated2003-08-21
Product QuantityNot stated. Irrelevant to recall strategy.

Reason for Recall

Misprinted radiographic template plates. Misprinted labeling.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K964220REPLACE TITANIUM IMPLANT SYSTEMSteri-Oss, Inc. · 1997-03-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑