Recall Z-0569-2008 ยท ELZ Crown, Preformed
3M Company / Medical Division
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.
| Date | Jan 24, 2008 (initiated Oct 17, 2007) |
| Status | Terminated |
| Reason | Mislabeled: Unitek Stainless Steel Permanent Molar Crowns were placed in packaging which incorrectly identified the product as Unitek Stainless Steel Primary Molar Crowns. |
| Root cause | Packaging process control |
| 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. |
| Quantity | 975 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.