FDA-Device2013-12-04Class III
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.
3M Company - Health Care Business
Hazard
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.
Sold states
Worldwide Distribution - USA including IN, TX, PA, FL, NV, SC, and TN and Internationally to Canada and Saudi Arabia.
Affected count
1419 (1325 US, 94 OUS)
Manufactured in
3M Center 2510 Conway Ave , B# 275-5-W-6, N/A, Saint Paul, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0428-2014Don't want to check this manually?
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