Bosworth Tray Aways #3 Disposable Impression Trays; styrene plastic perforated medium upper impression tray; The Boswort

FDA device recall Z-0420-05 · posted 2005-01-25 · Terminated

Recall details

Recalling firm

Harry J Bosworth Company

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.

Action taken

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

Status

Terminated

Product code

EHY

Quantity affected

13,904 trays

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

2006-04-24

Location

Skokie, IL