Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0419-05

Bosworth TruRepair Fast Bonding Repair Acrylic; the box contains one 8 oz. bottle of TruRepair liquid resin...

Harry J. Bosworth Co. / initiated 2004-09-23 / Terminated

Harry J Bosworth Company began a recall of Bosworth TruRepair Fast Bonding Repair Acrylic; the box contains one 8 oz. bottle of TruRepair liquid resin and two - 6 oz. bottles of TruRepair Powder; The... on . The reason FDA records is "The TruRepair denture repair kit contains Trusoft liquid resin instead of the TruRepair liquid resin. If teh Trusoft liquid is used the repair material will not set up". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0419-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Harry J. Bosworth Co.
Product
Bosworth TruRepair Fast Bonding Repair Acrylic; the box contains one 8 oz. bottle of TruRepair liquid resin and two - 6 oz. bottles of TruRepair Powder; The Bosworth Company, 7227 North Hamlin Avenue, Skokie, IL 60076-3999; catalog 092160
Product code
EDI
Reason for recall
The TruRepair denture repair kit contains Trusoft liquid resin instead of the TruRepair liquid resin. If teh Trusoft liquid is used the repair material will not set up.
FDA root cause
Other
Action
Customers were notified by telephone calls on 9/23/04. The accounts were informed of the mix-up with the liquids and were requested to return the kits for replacement.
Quantity in commerce
38 kits
Distribution
New York, Washington, New Jersey, Arizona, Minnesota, Wisconsin,Oregon and California.
Product codes and lots
lot number 0404-220, exp. 2007-04