Class 2 Device Recall

• Date Initiated by Firm: January 27, 2003
• Date Posted: February 25, 2003
• Recall Status: Terminated on August 21, 2003
• Recall Number: Z-0575-03
• Recall Event ID: 25471
• 510(K)Number: K964220
• Product: Nobel Biocare Replace Select Radiographic Template, part number 30159.
• Code Information: No codes apply. All physicians need to ensure the template is replaced.
• Recalling Firm/ Manufacturer: Nobel Biocare USA Inc; 22725 Savi Ranch Pkwy; Yorba Linda CA 92887
• For Additional Information Contact: Herbert Crane; 714-282-4800 Ext. 5074
• Manufacturer Reason for Recall: Misprinted radiographic template plates. Misprinted labeling.
• FDA Determined 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.

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code =