NA 204980Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848486021832), received between Oct 25, 2019 and Dec 2, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K141989, K170593); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2019Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  DURING REAMING THE MICS ATTACHMENT GOT STUCK ONTO THE REAMER SHAFT AND HAD TO BE HAMMERED OFF. CASE TYPE: THA. SURGICAL DELAY: 16-30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9396943 ↗
• MalfunctionOct 25, 2019Material Fragmentation; Separation Failure; Material Fragmentation; Separation Failure

  EVENT DESCRIPTION :THE ISSUE WAS THAT THE REAMER AND THE MICS ATTACHMENT STRIPPED THE METAL ON THE BACK OF THE STRAIGHT REAMER. CASE TYPE: THA. SURGICAL DELAY: =15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9237975 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141989, K170593. One submission often covers many models, so check the product and lot details in each record.

• Z-2745-2020 · Jul 9, 2020 · Terminated
  Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
• Z-3182-2018 · Dec 27, 2017 · Terminated
  Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated fo
• Z-3131-2017 · Aug 7, 2017 · Terminated
  Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries f
• Z-1411-2017 · Dec 22, 2016 · Terminated
  MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.