FDAClass IIIDecember 4, 2013

3M ESPE recall

3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are designed to fill the need for long term provisional coverage on…

Why was 3M ESPE 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are designed to fill the need for long term provisional coverage on…
Recalling firm
3M Company - Health Care Business
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.
Recall date
December 4, 2013
Classification
Class III
Status
Terminated
Agency
FDA (device)
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