3M Company - Health Care Business: Medical Device Recall in 2013 - (Recall #: Z-0428-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: June 5, 2013

Date Posted: December 4, 2013

Recall Number: Z-0428-2014

Event ID: 66509

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.

Status: Terminated

Product Quantity: 1419 (1325 US, 94 OUS)

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated