Reported Jul 26, 2017 · Terminated
MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software…
Mako Surgical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mako Surgical Corporation · 2555 Davie Rd Ste 110 · Davie, FL · 33317-7424
Is this the product you have?
- MAKO RIO Standard System
- internal cPCI Card CageP/N201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures
- Lot codes and dates
- Lot No. 05212015
- Amount recalled
- 20
Where it was sold
Why it was recalled
An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.
This product could cause temporary or reversible health problems — stop using it.
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