Reported Feb 22, 2017 · Terminated
Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components…
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?
- Stryker Restoris RIO Reamer Handle, Offset
- Mako Rx only Product UsageThe handle is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures
- Lot codes and dates
- All lots recalled, Catalog No. 207080.
- Amount recalled
- 595 units
Where it was sold
Why it was recalled
Failure of the Offset Cup Reamer Handle not engaging its mating components.
This product could cause temporary or reversible health problems — stop using it.
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