Mako Surgical Recalls MAKO RIO Standard System Card Cages
Mako Surgical Corporation is recalling 20 MAKO RIO Standard System internal cPCI Card Cages due to an intermittent electrical problem that could cause a loss of system power.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a loss of system power during a medical procedure, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Mako Surgical Corporation is recalling 20 units of the MAKO RIO Standard System, internal cPCI Card Cage (P/N: 201337, Lot No. 05212015). The device is intended to assist surgeons in providing software-defined spatial boundaries during orthopedic procedures.
The recall is due to an intermittent electrical problem that could lead to a loss of system power caused by a loose screw connection. The affected units were distributed to the states of Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Louisiana, Massachusetts, Missouri, Mississippi, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and Washington.
This is an FDA Class II recall. No specific instructions for consumers are provided in the source text, but the recall is initiated by the manufacturer to address the electrical defect.
The recalled product
- 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.
- Manufacturer
- Mako Surgical Corporation
- Affected units
- 20
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot No. 05212015
Distribution
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