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Recall Observatory FDA recall evidence

Device product

ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.

Z-0160-2018

November 06, 2014

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 77626
Status
Terminated
Classification
Class II
Quantity
31 units
Official record key
device-enforcement:Z-0160-2018

Official wording

Reason: Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).

Code information: Model No. 2.5.8., Serial No. RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033, RO14035, and RO14037.

Distribution pattern: US distribution in AR, GA, OH, MI, and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).