RESTORIS 160430Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00848486020644), received between Jun 20, 2018 and Sep 19, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Corroded” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2019Mechanical Problem; Mechanical Problem

  UPON RESETTING TRAYS, I NOTICED THAT THE POLY EXTRACTOR WAS STUCK IN THE CLOSED POSITION. I TRIED USING LUBRICANT TO "FREE" IT UP WITH NO SUCCESS. THE EXTRACTOR STICKS CLOSED EVERY TIME YOU SQUEEZE THE HANDLES TOGETHER. CASE TYPE: NO ASSOCIATED PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9088681 ↗
• MalfunctionJul 8, 2019Break; Break

  HANDLE OF POLY EXTRACTOR BROKE DURING POLY EXTRACTION. CASE TYPE: PKA. UPDATE: "NO DEBRIS/COMPONENTS LEFT INSIDE OF THE PATIENT. AND NO COMPONENTS OF THE DEVICE MISSING OR DISASSEMBLED WHEN THE ISSUE OCCURRED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8767781 ↗
• MalfunctionMar 5, 2019Corroded; Corroded

  IT WAS REPORTED THAT THE POLY EXTRACTOR HAS VISIBLE RUST.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8390291 ↗
• MalfunctionJul 3, 2018Bent; Bent

  INLAY INSERT EXTRACTOR BENT. PKA CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7658376 ↗
• MalfunctionJun 20, 2018Corroded; Corroded

  REP REPORTED THAT ON SALES BRANCH ADVICE, ALL SETS WERE INSPECTED AND A SECOND INSTRUMENT WAS FOUND RUSTED. NO ASSOCIATED PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 7622337 ↗

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