RESTORIS 160405Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00848486003203), received between Jul 2, 2018 and Oct 17, 2019 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2019Break; Fracture; Break; Fracture

  IMPACTOR CHIPPED UPON IMPACTING POLY IN. CASE TYPE: PKA. PATIENT WAS UNDER ANESTHESIA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9202288 ↗
• MalfunctionAug 27, 2019Material Integrity Problem; Material Integrity Problem

  BAD CONDITION. CASE TYPE: PKA. UPDATE: "THE SURGEON NOTICED THE TIP OF THE IMPACTOR WAS CHIPPED/CHIPPING. SHE ASKED THAT IT BE REPLACED"

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8934921 ↗
• MalfunctionApr 16, 2019Material Deformation; Material Deformation

  END OF IMPACTOR IS DEFORMED FROM YEARS OF USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8518201 ↗
• MalfunctionMar 12, 2019Break; Break

  IT IS REPORTED THAT THE INSTRUMENTS WERE DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8412774 ↗
• MalfunctionNov 29, 2018Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  INSERT IMPACTOR IS DAMAGED. CASE TYPE: PKA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8117145 ↗
• MalfunctionAug 6, 2018Material Too Rigid or Stiff; Material Too Rigid or Stiff

  POLY IMPACTOR IS VERY RIGID ON THE TIP DUE TO HITTING IMPLANT/METAL. CASE TYPE: PKA.

  Patient problems: No Patient Involvement

  MAUDE report 7754401 ↗
• MalfunctionJul 2, 2018Scratched Material; Scratched Material

  IT IS REPORTED THAT THE IMPACTOR HAS GROOVES. THIS LED TO DAMAGING THE ONLAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7655878 ↗

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-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-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