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Terminated

Bosworth 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,

FDA Recall Z-0420-05 · Posted 2005-01-25

Recalling FirmHarry J Bosworth Company
Recall StatusTerminated
Product CodeEHY
Date Initiated2004-10-13
Date Terminated2006-04-24
Product Quantity13,904 trays

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.

Firm Action

Bosworth 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.

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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