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U.S. Department of Health and Human Services

Class 3 Device Recall Bosworth Superbite Bite Registration Paste Kit

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 Class 3 Device Recall Bosworth Superbite Bite Registration Paste Kitsee related information
Date Initiated by FirmOctober 13, 2004
Date PostedJanuary 25, 2005
Recall Status1 Terminated 3 on April 26, 2006
Recall NumberZ-0421-05
Recall Event ID 30743
Product Classification Material, Impression - Product Code ELW
ProductBosworth 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
Code Information lot numbers 0407-376, exp. 2007-07; 0407-373, exp. 2007-07; 0407-526, exp. 2007-09
FEI Number 1410638
Recalling Firm/
Manufacturer		 Harry J Bosworth Company
7227 Hamlin Ave
Skokie IL 60076-3901
For Additional Information ContactMr. Christopher J. Lemme
847-679-3400
Manufacturer Reason
for Recall		The accelerator component of the kit hardens in the tube and cannot be used to prepare a workable impression paste.
FDA Determined
Cause 2		Other
ActionBosworth 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 Commerce436 kits
DistributionNationwide 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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