Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported December 4, 2013
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.
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
3M Company - Health Care Business recalled 3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are des… - a low-severity action.
3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are des… was recalled by 3M Company - Health Care Business in December 4, 2013. Reason: 3M is recalling specific lots of 3M ESPE Unitek Primary Stainless Steel Crowns - Series UR4 contain LL3 crow…. Check the official notice for the remedy. Verify recall #Z-0428-2014 with the FDA Devices before acting.
The recall
3M Company - Health Care Business issued this low-severity FDA Devices recall-3M is recalling specific lots of 3M ESPE Unitek Primary Stainless Steel Crowns - Series UR4 contain LL3 crow….
- Low
- severity level
- Class III
- classification
- December 4, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0428-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0428-2014) was formally reported on December 4, 2013, with the manufacturer initiating the action on June 5, 2013. It is classified under Low severity (Class III), with a current status of Terminated. 3M Company - Health Care Business is listed as the recalling firm, operating out of Saint Paul, MN. Federal records list the affected scope as 1419 (1325 US, 94 OUS).
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA including IN, TX, PA, FL, NV, SC, and TN and Internationally to Canada and Saudi Arabia.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1419 (1325 US, 94 OUS)
Related Recalls
6
3 from same agency
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0428-2014 |
| Date reported | December 4, 2013 |
| Date initiated | June 5, 2013 |
| Recalling firm | 3M Company - Health Care Business |
| Firm location | Saint Paul, MN |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0428-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by 3M Company - Health Care Business. Units affected: 1419 (1325 US, 94 OUS).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 4, 2013. Severity: Low. Recall number: Z-0428-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA including IN, TX, PA, FL, NV, SC, and TN and Internationally to Canada and Saudi Arabia..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0428-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 4, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.