RESTORIS, RIO 212760Recalls & reported problems
Mako Surgical Corp. · OFFSET CUP REAMER HANDLE · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Mako RIO offset cup reamer handle, a tool used in hip replacement surgery, appears in 670 adverse event reports, with no deaths and 2 injuries. Reports mostly describe parts detaching from the handle, especially missing screws, with some parts breaking. There are no recalls that name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 605
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 605 adverse event reports that list this exact device (DI 00848486032142), received between Jul 13, 2018 and Sep 30, 2026 — classified as 2 injuries, 603 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (572 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component572
- Component Missing95
- Break13
- Fracture10
- Material Fragmentation10
- Difficult to Insert6
- Mechanical Problem5
- Degraded4
Patient problems
- No Clinical Signs, Symptoms or Conditions586
- No Known Impact Or Consequence To Patient17
- Foreign Body In Patient2
- No Consequences Or Impact To Patient2
- Injury1
Recent adverse event reports
The 25 most recent of 605 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Detachment of Device or Device Component
Screws loose Case Type / Application: THA 5.0.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943274 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935694 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931158 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930871 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930663 ↗MalfunctionSep 25, 2026Detachment of Device or Device Component
6/8 screws missing from one reamer shaft. 5/8 in the other. Neither will pass registration and Spd says they will not sterilize again Case Type / Application: THA 5.0
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896108 ↗MalfunctionSep 25, 2026Detachment of Device or Device Component
MalfunctionSep 25, 2026Detachment of Device or Device Component
6/8 screws missing from one reamer shaft. 5/8 in the other. Neither will pass registration and Spd says they will not sterilize again. Case Type / Application: THA 5.0.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896100 ↗MalfunctionSep 23, 2026Detachment of Device or Device Component
Failed to pass registration, successful after changing reamer shafts.Case Type / Application: THA 4.1 .Update - The device is missing two screws, causing it not to function.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50866421 ↗MalfunctionSep 22, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858262 ↗MalfunctionSep 22, 2026Detachment of Device or Device Component
Mako offset reamer lost screws Case Type / Application: THA 5.0.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858261 ↗MalfunctionSep 22, 2026Detachment of Device or Device Component
Screw missing. Case Type / Application: THA 5.0.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858260 ↗MalfunctionSep 22, 2026Detachment of Device or Device Component
Screw detached during post-procedure cleaning.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855341 ↗MalfunctionSep 17, 2026Detachment of Device or Device Component
Notice screws were missing from offset reamer during case set up. Case Type / Application: THA 4.1
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50799183 ↗MalfunctionSep 11, 2026Detachment of Device or Device Component
The following event was reported: "Mako THA case ¿ noted that screws were loose on the offset reamer following ¿ piece needs replacing."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50733268 ↗MalfunctionSep 11, 2026Component Missing
Sweep of SPD. Case Type/Application: No, Associated Procedure. Update on 08/13/2026: Screws missing from device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50732543 ↗MalfunctionSep 11, 2026Detachment of Device or Device Component
The following information was provided: screw from reamer handle fell out during the decontamination process. The screw was found prior to the instrument being packed and sterilized and instrument set aside. THA 4.1/ ROB1109.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50728344 ↗MalfunctionSep 11, 2026Detachment of Device or Device Component
The following information was provided: Screw disengaged from offset reamer handle. Case Type/Application: THA 5.0.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50728343 ↗MalfunctionSep 11, 2026Detachment of Device or Device Component
Doctor requested to replace hip instruments. Case Type/Application: THA 4.2 Update on 08/18/2026: The device is missing four (4) screws.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50728024 ↗MalfunctionSep 10, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721721 ↗MalfunctionSep 10, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721720 ↗MalfunctionSep 10, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721719 ↗MalfunctionAug 27, 2026Detachment of Device or Device Component
Screw missing.Case Type / Application: THA 5.0.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50476588 ↗MalfunctionJun 23, 2026Component Missing; Detachment of Device or Device Component
THE FOLLOWING INFORMATION WAS PROVIDED: OFFSET REAMER SPLIT - APPEARS TO BE MISSING SCREWS THAT HOLD IT TOGETHER. CASE TYPE / APPLICATION: THA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25598535 ↗MalfunctionJun 4, 2026Detachment of Device or Device Component
THE FOLLOWING INFORMATION WAS PROVIDED: SCREW FELL OUT OF REAMER ATTACHMENT. CASE TYPE / APPLICATION: THA 4.1.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25391100 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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