RESTORIS 160195Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00848486003128), received between Jul 25, 2018 and Apr 30, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2019Break; Break

  BLUE PLASTIC COVER ON MAKO PKA BASEPLATE TIBIAL IMPACTOR BROKE DURING USE IN A CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8566525 ↗
• MalfunctionNov 28, 2018Crack; Fracture; Crack; Fracture

  INTRA-OP TIBIAL TRAY IMPACTOR HAD A CRACK IN IT AND IS NO LONGER USABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8112861 ↗
• MalfunctionAug 14, 2018Break; Fracture; Break; Fracture

  BLUE PLASTIC TIP TIBIAL IMPACTOR BROKE (RESTORIS MCK). AFTER NUMEROUS CYCLES THROUGH AN AUTOCLAVE, THE POLYMER WEARS OUT.

  Patient problems: No Patient Involvement

  MAUDE report 7780605 ↗
• MalfunctionJul 25, 2018Fracture; Fracture

  TIBIAL IMPACTOR TIP IS BROKEN IN HALF AND WAS THROWN AWAY DURING THE CASE. PKA PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7718836 ↗

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