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RESTORIS 170515Recalls & reported problems

Mako Surgical Corp. · MCK FEMORAL TRIAL (SIZE 5 RM/LL) · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848486003586), received between Oct 7, 2019 and Oct 7, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K082172, K090763); 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

Device problems

  • Break1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 7, 2019Break; Break

    OPENED UP TRAY IN SPD DUE TO BROKEN T-HANDLE AND FOUND THE THREADED TIP EMBEDDED IN THE TRIAL. CASE TYPE: NO ASSOCIATED PROCEDURE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9161302 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082172, K090763. One submission often covers many models, so check the product and lot details in each record.

  • Z-1385-2023 · Mar 10, 2023 · Open, Classified
    stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure
  • Z-1386-2023 · Mar 10, 2023 · Open, Classified
    stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
  • Z-2051-2018 · Jan 19, 2018 · Terminated
    Restoris MCK Onlay Insert Extractor.
  • Z-1031-2016 · Jan 15, 2016 · Terminated
    Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
  • Z-1132-2014 · Jan 9, 2014 · Terminated
    Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartme

Other PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.