Recall Z-0452-2016— Zimmer, Inc.

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2015-11-10, terminated 2016-02-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece. Rx only Made in Switzerland. Reason: The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected..

Recalling firm
Zimmer, Inc.
Classification
Class II
Status
Terminated
Initiated
2015-11-10
Terminated
2016-02-19
Firm location
Warsaw, IN, United States

Product description

Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece. Rx only Made in Switzerland

Reason for recall

The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected.

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