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Recall Observatory FDA recall evidence

Device product

Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance

Z-1512-2017

February 28, 2017

Class II

Product summary

Firm
Devicor Medical Products Inc
Event
Event 76603
Status
Terminated
Classification
Class II
Quantity
320
Official record key
device-enforcement:Z-1512-2017

Official wording

Reason: The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number.

Code information: F11621304D1

Distribution pattern: Worldwide Distribution - US including IA, IL, NY, OH, OK, PA, TN & WV. Internationally to Chile and Brazil

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number.