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RESTORIS 170615Recalls & reported problems

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

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848486003746), received between Feb 16, 2023 and Feb 16, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

4 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.

Recalls naming this device

  1. Mar 10, 2023Open, Classified

    Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking

    Z-1385-2023 · Root cause: Process change control · FDA record ↗

Most reported problems

Device problems

  • Inadequacy of Device Shape and/or Size1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionFeb 16, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    IT WAS REPORTED THAT DURING A DELIVERING MAKO INSTRUMENTS, OUR SALES STAFF NOTICED A DISCREPANCY OF SHAPE (SIZE). THERE WAS "RM/LL SIZE 5" BUT IT WAS ACTUALLY SIZE 6 SHAPE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16385250 ↗

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-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, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER devices

All PROSTHESIS, KNEE, FEMOROTIBIAL, 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.