Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-3130-2017 — Makoplasty Partial Knee Application (PKA) Product Usage: The 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.

U.S. FDA — Device Enforcement · United States · 2017-08-07 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-3130-2017
Date of alert: 2017-08-07
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Mako Surgical Corporation
Product category: device
Product type: Devices

Reported risk: Software discrepancy of not showing all the EE constants, when the screen is filled.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Related