FDA Medical Device Recalls (openFDA)
3M Company / Medical Division: 3M ESPE Stainless Steel Primary Molar Crowns, Made in USA by 3M ESPE Dental Products, St Paul, MN. Unitek" Primary Stainless Steel Crowns- Series UL3 and UR3 Product Code 900223, 900213, 902150
- Recall number
- Z-0463-2011
- Recalling firm
- 3M Company / Medical Division
- Product
- 3M ESPE Stainless Steel Primary Molar Crowns, Made in USA by 3M ESPE Dental Products, St Paul, MN. Unitek" Primary Stainless Steel Crowns- Series UL3 and UR3 Product Code 900223, 900213, 902150
- Status
- Terminated
- Initiated
- 2010-10-06
- Posted
- 2010-11-26
- Terminated
- 2012-02-04
- Reason
- Unitek Stainless Steel Permanent Crowns with product Codes 902150, 900213, and 900223, is mislabeled. The crown contained within the package is incorrectly labeled; series UL3 crowns are labeled series UR3 and vice versa. The lid of the package correctly identified the product number and lot. This mislabeling could result in placement on the right side of a crown intended for use on the left, and
- Root cause
- Packaging process control
- Action
- 3M ESPE issued a Device Recall letter dated October 6, 2010 to distributors and dentists. The letter listed the product being recalled including code and lot codes, background information including a picture of the product problem, and the recall procedure. The letter included a template letter to be used by distributors to inform their customers who have received the product. Mislabeled product is to be quarantined and returned to 3M ESPE. 3M ESPE can be contacted at 651 733-1110.
- Quantity
- 9819
- Distribution
- Nationwide Distribution: Throughout USA, including the states of AZ, CA, GA, IL, IN, IA, LA, MA, MN, MO, NV,NJ, NY, NC, PA, TN, TX, WA, and WI. Canada and Dominican Republic
- Lot, serial or model codes
- Product Code 900223 (Refill) " Lot codes N161092, N195115, N171401,N172028,N181008 Product Code 900213 (Refill) " Lot codes N161243, N168400, N181006, N186982, N195318 Product Code 902150 (Kit) " Lot Codes N155749, N170175, N193318
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ELZ
- Firm FEI
- 2110898
- 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