Device recall

Z-1124-2022: HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4

FDA device recall · Class II · Devicor Medical Products Inc

Key facts

Recall number (Z-number) Z-1124-2022
Recall event 90119
Product HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Product code NEU
Recalling firm Devicor Medical Products Inc
Recall class Class II
Status Terminated
Termination date Apr 30, 2024
510(k) numbers K210752
FEI number 3008492462

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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