3M ESPE Unitek Primary Stainless Steel Crowns — Class II medical device recall Z-2100-2013
Terminated recall by 3M Company/3m Espe Dental Products, reported 2013-09-04, distributed nationwide. 3M ESPE is recalling Unitek Primary Stainless Steel Crowns (First Primary UL4) because these products have bee
| Recall number | Z-2100-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | 3M Company/3m Espe Dental Products, Saint Paul, MN, United States |
| Recall initiated | 2013-08-05 |
| Classified | 2013-08-27 |
| Reported by FDA | 2013-09-04 |
| Terminated | 2013-12-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Lot numbers | N486012, N492036, N497616, N500930 |
Product
3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit) and 900114 (Refill- 5 crowns/box). Product Usage: 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 ESPE is recalling Unitek Primary Stainless Steel Crowns (First Primary UL4) because these products have been manufactured with the incorrect marginal contour edge.
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-2100-2013. 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.