Mako Surgical Corporation recalls MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defi…
- Recall date
- June 7, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2741-2017
- FDA classification
- Class II
- Brand / firm
- Mako Surgical Corporation
- Sold / distributed
- Distributed to the states of AZ, CA, CO, CT, FL, GA, ID, LA, MA, MO, MS, NC, OH, PA, TN, TX, & WA.
Why it was recalled
An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.
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