MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.
Reported: July 26, 2017 Initiated: June 7, 2017 #Z-2741-2017
Product Description
MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.
Reason for Recall
An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.
Details
- Recalling Firm
- Mako Surgical Corporation
- Units Affected
- 20
- Distribution
- Distributed to the states of AZ, CA, CO, CT, FL, GA, ID, LA, MA, MO, MS, NC, OH, PA, TN, TX, & WA.
- Location
- Davie, FL
Frequently Asked Questions
What product 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.. Recalled by Mako Surgical Corporation. Units affected: 20.
Why was this product recalled? ▼
An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 26, 2017. Severity: Moderate. Recall number: Z-2741-2017.
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