Medical device recalls Moderate risk

Zimmer, Inc. recalls Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger Handpiece. Rx only Made in Switzerland

Recall date
November 10, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0453-2016
FDA classification
Class II
Brand / firm
Zimmer, Inc.
Sold / distributed
US Distribution to the states of : AR, CA, CO, CT, FL, GA, HI, IL, KS, KY, LA, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, PA, RI, SC, TX, UT, VA, WA, WI, WV and WY.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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