Z-0421-05

Bosworth Superbite Zinc Oxide Eugenol Bite Registration Paste Kit; the kit consists of one 3.25 oz. tube of...

Name: Z-0421-05 Bosworth Superbite Zinc Oxide Eugenol Bite Registration Paste Kit; the kit consists of one 3.25 oz. tube of...
Creator: Harry J Bosworth Company
Published: 2004-10-13
License: https://open.fda.gov/license/

Harry J. Bosworth Co. / initiated 2004-10-13 / Terminated

FDA source

Harry J Bosworth Company began a recall of 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 -... on 2004-10-13. The reason FDA records is "The accelerator component of the kit hardens in the tube and cannot be used to prepare a workable impression paste". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0421-05
Status: Terminated
Initiated: 2004-10-13
Posted: 2005-01-25
Terminated: 2006-04-26
Recalling firm: Harry J. Bosworth Co.
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
Product code: ELW Material, Impression
Reason for recall: The accelerator component of the kit hardens in the tube and cannot be used to prepare a workable impression paste.
FDA 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 in commerce: 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
Product codes and lots: lot numbers 0407-376, exp. 2007-07; 0407-373, exp. 2007-07; 0407-526, exp. 2007-09

Product code ELW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)