FDA Device recall Z-0428-2014
3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are designed to fill the need for long term provisional cove…
- FDA Device
- Class III
- terminated
- Published 2013-12-04
On 2013-12-04 the FDA classified a Class III recall of 3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are designed to fill the need for long term provisional cove… by 3m Health Care Business, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0428-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-06-05 |
| Published | 2013-12-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | 3m Health Care Business |
| Distribution | FL, IN, NV, PA, SC, TN, TX |
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
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.
Identifiers
| code_info | Product Code 902150 (Kit) ¿ Lot Codes N484233 and N463186 Product Code 900224 (Refill) ¿ Lot Codes N466509 and N473723 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0428-2014%22
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