Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall 3M ESPE Stainless Steel Primary Molar Crowns

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 3 Device Recall 3M ESPE Stainless Steel Primary Molar Crowns see related information
Date Initiated by Firm October 06, 2010
Date Posted November 26, 2010
Recall Status1 Terminated 3 on February 04, 2012
Recall Number Z-0463-2011
Recall Event ID 57115
Product Classification Crown, preformed - Product Code ELZ
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
Code Information 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 
Recalling Firm/
Manufacturer		 3M Company / Medical Division
3M Center, Bldg 275-05-W-06
Saint Paul MN 55144
For Additional Information Contact
651-733-1000
Manufacturer Reason
for Recall		 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
FDA Determined
Cause 2		 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 in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-