Recall Z-0421-05 ยท ELW Material, Impression
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
| Date | Jan 25, 2005 (initiated Oct 13, 2004) |
| Status | Terminated |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.