Device recall

Z-0362-2007: Suros ATEC Breast Biopsy System handpiece (9 gauge cannula 12 centimeters in…

FDA device recall · Class II · Suros Surgical Systems Inc.

Key facts

Recall number (Z-number) Z-0362-2007
Recall event 37071
Product Suros ATEC Breast Biopsy System handpiece (9 gauge cannula 12 centimeters in length with a 20 millimeter aperture) for use with the ATEC Breast Biopsy and Excision System, disposable, sterile; Part no. 0912-20.
Product code KNW
Recalling firm Suros Surgical Systems Inc.
Recall class Class II
Status Terminated
Termination date May 4, 2007
510(k) numbers K010400, K042290
FEI number 3003862400

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)