FDA Recall Terminated

Nobel Biocare Replace Select Radiographic Template, part number 30159.

Recall: Z-0575-03 · Initiated January 27, 2003

Recall

Recall Number
Z-0575-03
Event Number
25471
Firm
Nobel Biocare USA Inc
FEI Number
1000125598
Status
Terminated
Root Cause
Other
Initiated
January 27, 2003
Posted
February 25, 2003
Terminated
August 21, 2003
Address
22725 Savi Ranch Pkwy, Yorba Linda, CA, 92887

Description

Nobel Biocare Replace Select Radiographic Template, part number 30159.

Reason

Misprinted radiographic template plates. Misprinted labeling.

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.

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.

Quantity

Not stated. Irrelevant to recall strategy.