3M 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.
This recall has been terminated (originally issued January 24, 2008).
- Recall Initiated
- October 17, 2007
- Posted
- January 24, 2008
- Terminated
- October 17, 2008
- Recall Number
- Z-0569-2008
- Quantity
- 975
- Firm Location
- South St Paul, MN
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution USA including states of TX, IN, FL, NV, KY, TN, MN, WA, NJ, PA, IL, CA, and IA, and country of CANADA.
Lot / Code Info
Lot #: P060928
Root Cause
Packaging process control
Action Taken
3M 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.