FDA Enforcement
Class III
Terminated
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.
Recall: Z-0428-2014
·
Reported December 4, 2013
Enforcement
- Recall Number
- Z-0428-2014
- Event ID
- 66509
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- 3M Company - Health Care Business
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 4, 2013
- Initiation Date
- June 5, 2013
- Classification Date
- November 27, 2013
- Termination Date
- December 11, 2013
- Address
- 3M Center 2510 Conway Ave , B# 275-5-W-6, N/A, Saint Paul, MN, 55144, United States
Description
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.
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 Info
Product Code 902150 (Kit) ¿ Lot Codes N484233 and N463186 Product Code 900224 (Refill) ¿ Lot Codes N466509 and N473723
Distribution
Worldwide Distribution - USA including IN, TX, PA, FL, NV, SC, and TN and Internationally to Canada and Saudi Arabia.
Quantity
1419 (1325 US, 94 OUS)