Recall Z-1043-04 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
Lang Dental Mfg Co, Inc.
Jet Denture Repair Acryulic, fast curing denture repair resin; Lang Dental Manufacturing Co., Inc., Wheeling, IL 60090-0969; product code 1220, 100 gram plastic squeeze bottle and product code 1223 100 gram plastic squeeze bottle, professional package
| Date | Jul 20, 2004 (initiated Jun 7, 2004) |
| Status | Terminated |
| Reason | The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene. |
| Root cause | Other |
| Action | Lang Dental sent recall letters dated 6/7/04 to their direct accounts, informing them of the contamination of the acrylic resin powders with the black particles and requesting the return of any existing inventory of the affected lots of product for replacement. Distributors were requested to sub-recall the products from their accounts. Follow-up letters were sent to the accounts on 6/14/04, clarifying the lot numbers affected to include both the lot number on the box and the lot number on the bottom of the squeeze bottles affected. |
| Quantity | 27 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.