CLASS III Device recall · Reported 4 Dec 2013 · FDA Enforcement Report

3M ESPE, Unitek Stainless Steel Permanent Molar Crowns recalled

3M Company - Health Care Business is recalling 3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are, distributed nationwide in the US. The recall was initiated on 5 Jun 2013 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesProduct Code 902150 (Kit) ¿ Lot Codes N484233 and N463186 Product Code 900224 (Refill) ¿ Lot Codes N466509 and N473723

Quantity recalled1419 (1325 US, 94 OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0428-2014
FDA event ID: 66509
Recalling firm: 3M Company - Health Care Business, Saint Paul, MN
Classification: Class III
Status: Terminated
Recall initiated: 5 Jun 2013
FDA classified: 27 Nov 2013
Reported: 4 Dec 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

5 Jun 2013	Recall initiated by company
27 Nov 2013	Classified by FDA	+175 days
4 Dec 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution - USA including IN, TX, PA, FL, NV, SC, and TN and Internationally to Canada and Saudi Arabia.

Nationwide Florida Nevada Pennsylvania South Carolina Tennessee Texas

Questions about this recall

Is 3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are recalled?

Yes. 3M Company - Health Care Business recalled 3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are on 5 Jun 2013. The recall is Class III and its status is Terminated. Recall number Z-0428-2014.

Why was it recalled?

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.

Which lots are affected?

Product Code 902150 (Kit) ¿ Lot Codes N484233 and N463186 Product Code 900224 (Refill) ¿ Lot Codes N466509 and N473723

Where was it sold?

Worldwide Distribution - USA including IN, TX, PA, FL, NV, SC, and TN and Internationally to Canada and Saudi Arabia.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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