Recall Z-0981-2015— Straumann USA, LLC

Class II · Terminated

Class II FDA medical device recall by Straumann USA, LLC, initiated 2014-10-27, terminated 2015-04-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set.. Reason: Drill set may contain incorrect drill..

Recalling firm
Straumann USA, LLC
Classification
Class II
Status
Terminated
Initiated
2014-10-27
Terminated
2015-04-10
Firm location
Andover, MA, United States

Product description

Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set.

Reason for recall

Drill set may contain incorrect drill.

Data sourced from openFDA. This site is unofficial and independent of the FDA.