Recall Z-0428-2014 ยท ELZ Crown, Preformed
3M Company - Health Care Business
3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth.
| Date | Nov 27, 2013 (initiated Jun 5, 2013) |
| Status | Terminated |
| Reason | 3M is recalling specific lots of 3M ESPE Unitek Primary Stainless Steel Crowns - Series UR4 contain LL3 crowns which are incorrectly labeled as UR4 crowns. |
| Root cause | Process control |
| Action | 3M Company sent a Voluntary Recall letterdated June 4, 2013, to all affected consignees. The letter described the problem and the product involved in the recall. Advised consignees to review their inventory and quarantine the product and do not further distribute it. For replacement they should call Customer Service at 3M ESP Dental Products at 1-800-237-1650. If they have further distributed the product they requested they contact their customers to inform them of the recall. 3M prepared a letter to be used in their communications with their customers. The customers should contact 1-80 |
| Quantity | 1419 (1325 US, 94 OUS) |
| Distribution | Worldwide Distribution - USA including IN, TX, PA, FL, NV, SC, and TN and Internationally to Canada and Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.