RESTORIS 180612Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848486000752), received between Oct 13, 2017 and Jun 28, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Packaging Problem” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K082172, K090763, K150307, K220930, K242831); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ON OR ABOUT (B)(6) 2021, THE PATIENT UNDERWENT BILATERAL KNEE SURGERY PARTIAL ARTHROPLASTY, PATELLOPLASTY, EXCISION OF BENIGN BONE AND BAKER'S CYST ON THE LEFT AND ORIF OF THE RIGHT TIBIAL PLATEAU. ALLEGEDLY THE PATIENT WAS REQUIRED TO UNDERGO MORE EXTENSIVE SURGERY TO RIGHT KNEE INVOLVING A VARIETY OF SCREWS, WIRES, PINS, WASHERS, AND OTHER HARDWARE TO ANATOMICALLY REDUCE, STABILIZE AND COMPRESS ACROSS THE FRACTURE LINE WHICH RESULTED DURING SURGERY. IT IS FURTHER ALLEGED THAT SHE SUFFERS FROM IRREPARABLE PERSONAL INJURIES INCLUDING, BUT NOT LIMITED TO, RIGHT KNEE PAIN, DIMINISHED STRENGTH, AND OTHER SYMPTOMS.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Pain

  MAUDE report 17214877 ↗
• MalfunctionOct 13, 2017Packaging Problem; Packaging Problem

  AFTER IMPLANTING THE COMPONENTS, WE WERE REVIEWING THE USAGE FORM AND SAW THAT THE IMPLANT BOX SAID TIBIAL BASEPLATE SIZE 2RM/LL AND THE IMPLANT STICKER SAID, "7RM/LL". THE IMPLANT WAS THE CORRECT SIZE AND WE WERE ABLE TO FINISH WITHOUT ANY ISSUES. PKA PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6949853 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082172, K090763, K150307, K220930, K242831. 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