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Terminated

Robotic Arm Interactive Orthopedic System (RIO)

FDA Recall Z-1508-2016 · Posted 2016-04-18

Recalling FirmMako Surgical Corporation
Recall StatusTerminated
Product CodeOLO
Date Initiated2014-04-30
Date Terminated2019-07-24
Product Quantity249

Reason for Recall

Revision of the field manual

Firm Action

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.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Italy, Japan, Hong Kong, Scotland, Germany, Turkey , Greece, Singapore, Taiwan and South Korea.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121064MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEMMako Surgical Corporation · 2012-06-06K112507RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEMMako Surgical Corporation · 2012-03-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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