FDA Medical Device Recalls (openFDA)
Nobel Biocare USA Inc: Nobel Biocare Replace Select Radiographic Template, part number 30159.
- Recall number
- Z-0575-03
- Recalling firm
- Nobel Biocare USA Inc
- Product
- Nobel Biocare Replace Select Radiographic Template, part number 30159.
- Status
- Terminated
- Initiated
- 2003-01-27
- Posted
- 2003-02-25
- Terminated
- 2003-08-21
- 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, Russia, San Marino, Sardina, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Virgin Islands.
- Lot, serial or model codes
- No codes apply. All physicians need to ensure the template is replaced.
- 510(k) numbers
- ["K964220"]
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 1000125598
- Firm city
- Yorba Linda
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28