Recall Z-0419-05 ยท EDI
Harry J Bosworth Company
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
| Date | Jan 25, 2005 (initiated Sep 23, 2004) |
| Status | Terminated |
| 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. |
| 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 | 38 kits |
| Distribution | New York, Washington, New Jersey, Arizona, Minnesota, Wisconsin,Oregon and California. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.