ROSA® Recon 20-8020-110-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00889024511170), received between May 8, 2023 and Sep 25, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (4 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Unintended System Motion

  It was reported that during surgery the system generated multiple collision errors and the arm shook when moved to the cut position. There was no patient involvement. The Force Torque sensor cable was found to be the cause of this unintended movement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898876 ↗
• MalfunctionSep 22, 2026Unintended System Motion

  It was reported that during a ROSA Knee procedure, the robotic arm drifted after the 4-in-1 cuts. Subsequently, the surgeon completed the procedure using manual instrumentation. There was no adverse patient outcome. Follow-ups to gather additional information are currently in process.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855312 ↗
• MalfunctionApr 28, 2026Unintended Movement

  IT WAS REPORTED THAT AFTER COMPLETING A SYSTEM TEST, THE TEST ARM DRIFTED. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015660 ↗
• MalfunctionFeb 23, 2026Unintended System Motion; Output Problem

  IT WAS REPORTED THAT COLLISION ERRORS AND ARM DRIFTING WERE EXPERIENCED WHILE USING THE ROSA PLATFORM. NO PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24417867 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A ROSA SHOULDER PROCEDURE, REAMING RESULTED IN AN OBLONG HOLE DUE TO HARD BONE. THE SURGEON GRAFTED THE OBLONG DEFECT CREATED BY THE REAMING. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Notching

  MAUDE report 24316286 ↗
• MalfunctionSep 9, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THE CUT BLOCK STARTED SPINNING OUT OF NOWHERE IN THE MIDDLE OF CASE, ROTATING WHEN FOOT WAS ON PEDAL TO DISENGAGE. NO PATIENT HARM OR INJURY. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23012163 ↗
• MalfunctionJun 9, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THE ISSUE APPEARED AS WE WERE MAKING A DISTAL FEMUR RESECTION. THE ARM APPEARED TO DRIFT WHILE IN COLLABORATIVE MODE. THE ARM CONTINUED TO MOVE UNTIL IT MADE CONTACT WITH THE BASE REFERENCE TRACKER. AT WHICH TIME THE ROSA WAS PUT INTO COLLABORATIVE MODE BUT WHEN THE DOCTOR ATTEMPTED TO PULL THE ARM OFF THE BASE TRACKER, HE HAD TO PULL SO HARD THE ENTIRE BASE MOVED. THE ROSA CASE WAS ABORTED AND PROCEEDED WITH MANUAL INSTRUMENTATION FOR THE DISTAL FEMUR CUT. NO HARM TO THE PATIENT. PROPER TECHNIQUE AND SETUP WERE UTILIZED DURING THE CASE. THERE WAS NOTHING OBSTRUCTING THE VIEW OF THE NAVITRACKERS AT THE TIME OF THE DRIFTING NOR HAD ANY OF THEM BEEN MOVED TO THEIR KNOWLEDGE. DURING CORRECTIVE MAINTENANCE, A BAD FORCE SENSOR CABLE WAS FOUND. THE CABLE HAS BEEN REPLACED AND UNIT TESTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169528 ↗
• MalfunctionJun 9, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING SURGERY THE SYSTEM AGGRESSIVELY PULLED AWAY FROM THE PATIENT. THIS WAS NOT LIKE THE DRIFT THAT HAS BEEN SEEN IN THE PAST. DURING CORRECTIVE MAINTENANCE, IT WAS DISCOVERED THAT THE FORCE TORQUE SENSOR AND CABLE WERE WORN. THE ROBOT ARM WAS DRIFTING AND RESISTING DURING THE ARM ACCURACY TEST. THERE WAS NO HARM OR IMPACT TO THE PATIENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167570 ↗
• MalfunctionMay 27, 2025Sparking; Sparking

  IT WAS REPORTED THAT THE CABLE INSERT PIN WAS FOUND DAMAGED AND THAT A SMALL SPARK OCCURS WHEN IT IS PLUGGED IN. NO ADDITIONAL INFORMATION AVAILABLE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22091111 ↗
• MalfunctionNov 15, 2023Data Problem; Data Problem

  IT WAS REPORTED ROSA UNIT WOULD NOT ALLOW CASE DATA TO LAUNCH. NO PATIENT HARM OR INJURY. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18141946 ↗
• MalfunctionNov 9, 2023Connection Problem; Connection Problem

  IT WAS REPORTED DURING A ROSA KNEE PROCEDURE THAT THE UNIT PRESENTED AN UNKNOWN ROBOTIC ERROR. THE CORD GOING INTO THE FORCE SENSOR SEEMED LOOSE. AFTER THE PROCEDURE, THE UNIT¿S POWER WENT OUT. NO PATIENT HARM, INVOLVEMENT, IMPACT OR INJURY. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18101062 ↗
• InjuryMay 8, 2023Output Problem; Output Problem

  NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16885277 ↗