Recall Z-0428-2014— 3M Company - Health Care Business
Class III · Terminated
Class III FDA medical device recall by 3M Company - Health Care Business, initiated 2013-06-05, terminated 2013-12-11. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- 3M Company - Health Care Business
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2013-06-05
- Terminated
- 2013-12-11
- Firm location
- Saint Paul, MN, United States
Product 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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.