FDA Device

Robotic Arm Interactive Orthopedic System (RIO)

Hazard

Revision of the field manual

What You Should Do

Remedy

As per our conversation with firm representative on March 23, 2016, they stated "no notification was sent to the customers", and referred to Ref: Part 806 File number: RA 2015-017 where it states "Stryker Orthopaedics has completed a retrospective review of other revisions to the field service manual, and we have confirmed there are no other similar events for which Part 806 reports should have been submitted". For further questions, please call (866) 647-6256. Internal actions taken only.

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Products

Robotic Arm Interactive Orthopedic System (RIO)
Brand
Mako Surgical Corporation
UPC
Catalog # 203900 & 207092 All lots

Units Affected

249

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