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U.S. Department of Health and Human Services

Class 3 Device Recall Unitek Stainless Steel Permanent Molar Crowns

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 Class 3 Device Recall Unitek Stainless Steel Permanent Molar Crownssee related information
Date Initiated by FirmOctober 17, 2007
Date PostedJanuary 24, 2008
Recall Status1 Terminated 3 on October 17, 2008
Recall NumberZ-0569-2008
Recall Event ID 45951
Product Classification Preformed Crowns - Product Code ELZ
Product3M ESPE Unitek Stainless Steel Permanent Molar Crowns , Product Code: 900321, Made in U.S.A by 3M ESPE Dental Products St. Paul, MN 55144-1000.
Code Information Lot #: P060928
Recalling Firm/
Manufacturer		 3M Company / Medical Division
3M Center, Bldg 275-05-W-06
South St Paul MN 55144
For Additional Information Contact
651-733-1000
Manufacturer Reason
for Recall		Mislabeled: Unitek Stainless Steel Permanent Molar Crowns were placed in packaging which incorrectly identified the product as Unitek Stainless Steel Primary Molar Crowns.
FDA Determined
Cause 2		Packaging process control
Action3M ESPE Dental Products initially contacted Distributors and Doctors on 10/22/07 through telephone calls, and sent a Device Recall letter via Fed Ex - Overnight on 10/22/07. The letter informed the users that Unitek Stainless Steel Permanent Crowns Lot # P060928, Product Code 900321 may be mislabeled as Unitek Stainless Steel Primary Molar Crowns. Users were asked to stop using and/or distributing the product and contact ESPE Dental Products at 1-800-237-1650 to initiate product return and replacement.
Quantity in Commerce975
DistributionWorldwide Distribution USA including states of TX, IN, FL, NV, KY, TN, MN, WA, NJ, PA, IL, CA, and IA, and country of CANADA.
Total Product Life CycleTPLC 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.
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