RESTORIS 160141Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848486020163), received between Dec 23, 2019 and Dec 23, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inaccurate Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionDec 23, 2019Inaccurate Information; Inaccurate Information

  AS REPORTED BY A MAKO PRODUCT MANAGER: "IF WE ARE NOT WRONG, WE NOTICED A MISTAKE OF TRANSLATION FOR THE MAKO RESTORIS SIZE 1 FEMORAL TRIAL REF 160141...IN ENGLISH IT¿S LM/RL WHILE THE TRANSLATION IN FRENCH MEANS INTERNAL RIGHT/EXTERNAL LEFT."A .PDF SUPPLIED OF THE LABEL APPEARS TO BE A SAMPLE LABEL, NOT A PACKAGING LABEL. IT IS UNKNOWN IF ANY PHYSICAL LABELS/ DEVICES ARE INVOLVED AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9513167 ↗

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