| Date Initiated by Firm | September 23, 2004 |
|---|
| Date Posted | January 25, 2005 |
|---|
| Recall Status1 |
Terminated 3 on April 24, 2006 |
| Recall Number | Z-0419-05 |
|---|
| Recall Event ID |
30736 |
| Product Classification |
unknown device name - Product Code EDI
|
| 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 |
|---|
| Code Information |
lot number 0404-220, exp. 2007-04 |
| FEI Number |
1410638
|
Recalling Firm/
Manufacturer |
Harry J Bosworth Company
7227 Hamlin Ave
Skokie
IL
60076-3901
|
| For Additional Information Contact | Mr. Christopher J. Lemme
847-679-3400 |
|---|
Manufacturer 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 Determined
Cause 2 | 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. |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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