Recalling Firm / Manufacturer

3M Company / Medical Division

Product

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.

Code Information

Lot #: P060928

Reason of Recall

Mislabeled: Unitek Stainless Steel Permanent Molar Crowns were placed in packaging which incorrectly identified the product as Unitek Stainless Steel Primary Molar Crowns.

Date Recall Initiated

October 17, 2007

Action

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.

Contact

3M company
Riyadh
(01) 2171324

Source of Information

U.S.FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.