FDA Medical Device Recalls (openFDA)
Harry J Bosworth Company: Bosworth Superbite Zinc Oxide Eugenol Bite Registration Paste Kit; the kit consists of one 3.25 oz. tube of Accelerator - Blue, and one 7.5 oz. tube of Base - White, which are mixed as needed to make the registration paste; The Bosworth Company, 7227 North Hamlin Avenue, Skokie, IL 60076-3999; catalog 0921815
- Recall number
- Z-0421-05
- Recalling firm
- Harry J Bosworth Company
- Product
- Bosworth Superbite Zinc Oxide Eugenol Bite Registration Paste Kit; the kit consists of one 3.25 oz. tube of Accelerator - Blue, and one 7.5 oz. tube of Base - White, which are mixed as needed to make the registration paste; The Bosworth Company, 7227 North Hamlin Avenue, Skokie, IL 60076-3999; catalog 0921815
- Status
- Terminated
- Initiated
- 2004-10-13
- Posted
- 2005-01-25
- Terminated
- 2006-04-26
- Reason
- The accelerator component of the kit hardens in the tube and cannot be used to prepare a workable impression paste.
- Root cause
- Other
- Action
- Bosworth initiated a recall of two lots of the paste by telephone calls on 9/2/04,and expanded the recall to include a third lot of paste by undated letter on 10/13/04, sent to all of their customers. The letters informed the accounts that the accelerator component will solidify in the tube, and requested the accounts to return all of the Superbite Paste of the affected lots in stock for replacement. Follow-up letters dated 12/26/04 were sent to the consignees, requesting a response to the notification, indicating the amount of product being returned to Bosworth.
- Quantity
- 436 kits
- Distribution
- Nationwide and internationally to Canada, Australia, Hong Kong, Japan, Korea, Malaysia, New Zealand, Philippines, Singapore, Taiwan, Thailand, Vietnam, Bahrain, Iran, Israel, Jordan, Lebanon, Oman, Qatar, Saudi Arabia, Syria, Turkey, United Arab Emirates, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Netherlands, Norway, Portugal, Russia, Spain, Sweden, Switzerland, United Kingdom
- Lot, serial or model codes
- lot numbers 0407-376, exp. 2007-07; 0407-373, exp. 2007-07; 0407-526, exp. 2007-09
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ELW
- Firm FEI
- 1410638
- Firm city
- Skokie
- Firm state
- IL
- 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