Device recall

Z-2741-2017: MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist…

FDA device recall · Class II · Mako Surgical Corporation

Key facts

Recall number (Z-number) Z-2741-2017
Recall event 77553
Product MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.
Product code OLO
Recalling firm Mako Surgical Corporation
Recall class Class II
Status Terminated
Termination date Jun 16, 2020
510(k) numbers K112507
FEI number 3005985723

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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