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U.S. Department of Health and Human Services

Class 3 Device Recall Bosworth Tray Aways 3

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 Class 3 Device Recall Bosworth Tray Aways 3see related information
Date Initiated by FirmOctober 13, 2004
Date PostedJanuary 25, 2005
Recall Status1 Terminated 3 on April 24, 2006
Recall NumberZ-0420-05
Recall Event ID 30740
Product Classification Tray, Impression, Preformed - Product Code EHY
ProductBosworth Tray Aways #3 Disposable Impression Trays; styrene plastic perforated medium upper impression tray; The Bosworth Company, 7227 North Hamlin Avenue, Skokie, IL 60076-3999; 12 trays per bag; catalog 0921885,
Code Information catalog number 0921885, UPC +D68109218850G,  product with date stamps of 4/6/2004, 5/4/2004, 6/16/2004, 7/22/2004, 7/23/2004 and 8/16/2004
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 tray mold was improperly made such that the plastic trays do not conform to the shape of the patient's mouth.
FDA Determined
Cause 2		Other
ActionBosworth initiated a recall of the trays by undated letter on 10/13/04 sent to all of their customers. The letters informed the accounts that the Tray Away #3 did not meet their standards, and requested the accounts to return all of the Tray Away #3 trays 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 Commerce13,904 trays
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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