3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are designed to fill the need for long te

FDA device recall Z-0428-2014 · posted 2013-11-27 · Terminated

Recall details

Recalling firm

3M Company - Health Care Business

Reason for recall

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.

Action taken

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 1-800-634-2249. For questions regarding this recall call 651-733-5718.

Root cause

Process control

Status

Terminated

Product code

ELZ

Quantity affected

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.

Date initiated

2013-06-05

Date posted

2013-11-27

Date terminated

2013-12-11

Location

Saint Paul, MN