Recall Z-1512-2017— Devicor Medical Products Inc
Class II · Terminated
Class II FDA medical device recall by Devicor Medical Products Inc, initiated 2017-02-28, terminated 2017-08-03. It names one FDA 510(k) clearance: K152989. 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. 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..
- Recalling firm
- Devicor Medical Products Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-02-28
- Terminated
- 2017-08-03
- Firm location
- Cincinnati, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.