• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 3 Recall
3M ESPE Stainless Steel Primary Molar Crowns
see related information
Date Posted November 26, 2010
Recall Status1 Terminated 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, Minnesota 55144
Consumer Instructions Contact the recalling firm for information
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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
-
-