Recall Z-1041-04 ยท EBG Crown And Bridge, Temporary, Resin
Lang Dental Mfg Co, Inc.
Jet Tooth Shade Powder, a fast curing temporary crown and bridge acrylic; product code 1410, Net Wt. 45 g (2 oz.) plastic squeeze bottles and product code 1420, Net Wt. 100 g (4 oz.) plastic squeeze bottles; Lang Dental Manufacturing Co., Inc., Wheeling, IL 60090-0969
| 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 | 402 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.