Device product
3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth.
Z-0428-2014
Product summary
- Event
- Event 66509
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1419 (1325 US, 94 OUS)
- Official record key
device-enforcement:Z-0428-2014
Official wording
Reason: 3M is recalling specific lots of 3M ESPE Unitek Primary Stainless Steel Crowns - Series UR4 contain LL3 crowns which are incorrectly labeled as UR4 crowns.
Code information: Product Code 902150 (Kit) ¿ Lot Codes N484233 and N463186 Product Code 900224 (Refill) ¿ Lot Codes N466509 and N473723
Distribution pattern: Worldwide Distribution - USA including IN, TX, PA, FL, NV, SC, and TN and Internationally to Canada and Saudi Arabia.
Derived failure modes
-
Labeling or packaging
incorrectly labeled