3M ESPE — Class III medical device recall Z-0428-2014
Terminated recall by 3M Company - Health Care Business, reported 2013-12-04, distributed in FL, IN, NV, PA, SC, TN, TX. 3M is recalling specific lots of 3M ESPE Unitek Primary Stainless Steel Crowns - Series UR4 contain LL3 crowns
| Recall number | Z-0428-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | 3M Company - Health Care Business, Saint Paul, MN, United States |
| Recall initiated | 2013-06-05 |
| Classified | 2013-11-27 |
| Reported by FDA | 2013-12-04 |
| Terminated | 2013-12-11 |
| Distributed | FL, IN, NV, PA, SC, TN, TX |
| Countries outside the US | CA, SA |
| Reason classes | labeling |
| Lot numbers | N463186, N466509, N473723, N484233 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0428-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.