FDA Medical Device Recalls (openFDA)
3M Company/3m Espe Dental Products: 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.
- Recall number
- Z-2100-2013
- Recalling firm
- 3M Company/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.
- Status
- Terminated
- Initiated
- 2013-08-05
- Posted
- 2013-08-27
- Terminated
- 2013-12-11
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Product Code 902150 (Kit) ¿ Lot codes N492036, N500930 (not distributed) and N495695 Product Code 900114 (Refill) ¿ Lot Codes N486012, N497616 (not distributed) and N483920
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ELZ
- Firm FEI
- 3005174370
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28