FDA Recall
Terminated
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
Recall: Z-0419-05
·
Initiated September 23, 2004
Recall
- Recall Number
- Z-0419-05
- Event Number
- 30736
- Firm
- Harry J Bosworth Company
- FEI Number
- 1410638
- Product Code
- EDI
- Status
- Terminated
- Root Cause
- Other
- Initiated
- September 23, 2004
- Posted
- January 25, 2005
- Terminated
- April 24, 2006
- Address
- 7227 Hamlin Ave, Skokie, IL, 60076-3901
Description
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
Reason
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.
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.
Distribution
New York, Washington, New Jersey, Arizona, Minnesota, Wisconsin,Oregon and California.
Quantity
38 kits