Device recall

Z-0715-06: Rubicor EnCapsule Breast Biopsy Device, Part Number 31358, Product is…

FDA device recall · Class II · Rubicor Medical

Key facts

Recall number (Z-number) Z-0715-06
Recall event 34859
Product Rubicor EnCapsule Breast Biopsy Device, Part Number 31358, Product is manufactured and distributed by Rubicor Medical, Inc., 600 Chesapeake Dr., Redwood City, CA 94063
Product code GEI
Recalling firm Rubicor Medical
Recall class Class II
Status Terminated
Termination date May 11, 2006
510(k) numbers K020047, K023601, K030049, K032584, K052506
FEI number 3004014191

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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

Browse all FDA device recalls (products)