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Recall Observatory FDA recall evidence

Device product

ROSA Surgical Device 2.5.8

Z-0115-2018

April 08, 2016

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 77743
Status
Terminated
Classification
Class II
Quantity
64 units
Official record key
device-enforcement:Z-0115-2018

Official wording

Reason: Potential for software to change the final tool orientation for the command position without command.

Code information: Serial No. RO15050, RO15044, RO15048, RO15067, RO15045, RO15061, RO14041, RO14038, RO14039, RO14043, RO15051, RO15069, RO10011, RO14037, RO10014, RO15054, RO14035, RO15060, RO15063, RO14033, RO15059, RO15064, RO14031, RO14040, RO10009, RO13023, RO15053, RO15052, RO15058, RO13027, RO15046, and RO15062

Distribution pattern: AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, MO, NY, OH, PA, TX, and WA Canada, China, France, Germany, India, Israel, Italy, Russia, Saudi Arabia, Spain, and United Kingdom

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for software to change the final tool orientation for the command position without command.