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Recall Observatory FDA recall evidence

Device product

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

Z-0453-2016

November 10, 2015

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 72688
Status
Terminated
Classification
Class II
Quantity
89 units
Official record key
device-enforcement:Z-0453-2016

Official wording

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

Code information: Model # 01-8507-400-10 & Model # 89-8507-400-10

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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