Device recall

Z-1671-2015: EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter…

FDA device recall · Class II · Stryker Instruments Div. of Stryker Corporation

Key facts

Recall number (Z-number) Z-1671-2015
Recall event 71185
Product EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter tip, and 10 cm with and without HiLiter tip.
Product code KNW
Recalling firm Stryker Instruments Div. of Stryker Corporation
Recall class Class II
Status Terminated
Termination date Oct 15, 2015
510(k) numbers K112945
FEI number 1811755

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

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