FDAFDA · Food and drugs·Recall number Z-0428-2014
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.
Published December 4, 2013 · Recall initiated: June 5, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- 3M Company - Health Care Business
- Distributor
- Worldwide Distribution - USA including IN, TX, PA, FL, NV, SC, and TN and Internationally to Canada and Saudi Arabia.
- Lot
- Product Code 902150 (Kit) ¿ Lot Codes N484233 and N463186 Product Code 900224 (Refill) ¿ Lot Codes N466509 and N473723
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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