Z-2100-2013Class II

3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit)...

Name: Z-2100-2013 3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit)...
Creator: 3M Company/3m Espe Dental Products
Published: 2013-08-05
License: https://open.fda.gov/license/

3M ESPE Dental Products / initiated 2013-08-05 / Terminated / root cause: manufacturing process

FDA source

3M Company/3m Espe Dental Products began a recall of 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... on 2013-08-05. FDA classified it as Class II and gives the reason as "3M ESPE is recalling Unitek Primary Stainless Steel Crowns (First Primary UL4) because these products have been manufactured with the incorrect marginal contour edge". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2100-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-05
Posted: 2013-08-27
Terminated: 2013-12-11
Recalling firm: 3M ESPE Dental Products
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.
Product code: ELZ Crown, Preformed
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 3M ESPE sent a 3M "Voluntary Recall" letter dated August 1, 2013 to all affected customers. Separate letters were addressed to distributors and doctors. The letters described the product affected by the recall, problem and actions to be taken. The doctors were advised to complete the attached inventory checklist and call the 3M ESPE Dental Products Customer Care Center at 1-800-634-2249. Select option #1 to arrange for return and replacement of your product. Distributors were advised to quarantine and return the product and not to further distribute it. For product return they should contact 3M ESPE Dental Products Customer Service at 1-800-237-1650. If the product was further distributed they ask that they inform them of the recall. A letter was prepared that can be used for their communication to customers. for additional questions they should contact 651-733-7767.
Quantity in commerce: 3409 crowns (2949 US and 460 OUS)
Distribution: Worldwide Distribution - USA Nationwide in the states of CA, FL, GA, IN, IA, MO, NV, NJ, NY, PA, SC, TN, TX, WA. and the country of CANADA.
Product codes and lots: Product Code 902150 (Kit) ¿ Lot codes N492036, N500930 (not distributed) and N495695 Product Code 900114 (Refill) ¿ Lot Codes N486012, N497616 (not distributed) and N483920

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2100-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2100-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27

Product code ELZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)