Recall Z-0453-2016— 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 Single 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 Single 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.