Z-1512-2017 Class II Terminated
FDA device recall Z-1512-2017 was initiated by Devicor Medical Products Inc on February 28, 2017 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated August 3, 2017). Affected quantity: 320.
Recall Details
- Product Type
- Devices
- Report Date
- March 29, 2017
- Initiation Date
- February 28, 2017
- Termination Date
- August 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 320
Product Description
Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - US including IA, IL, NY, OH, OK, PA, TN & WV. Internationally to Chile and Brazil
Code Information
F11621304D1