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

FDA device recall Z-0421-05 · posted 2005-01-25 · Terminated

Recall details

Recalling firm

Harry J Bosworth Company

Reason for recall

The accelerator component of the kit hardens in the tube and cannot be used to prepare a workable impression paste.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

ELW

Quantity affected

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, Qa

Date initiated

2004-10-13

Date posted

2005-01-25

Date terminated

2006-04-26

Location

Skokie, IL