Reported Sep 20, 2017 · Terminated
Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist…
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?
- Total
- Hip Application (THA) Product UsageThe Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures
- Lot codes and dates
- All Lot codes
- Amount recalled
- 291 (US) and 66 (OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Software discrepancy of not showing all the EE constants, when the screen is filled.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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