RESTORIS 180414Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848486000493), received between Jun 12, 2019 and Jun 12, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2019Corroded; Contamination /Decontamination Problem; Packaging Problem; Corroded; Contamination /Decontamination Problem; Packaging Problem

  THE IMPLANT WAS FOUND CONTAMINATED IN THE PACKAGING AT THE TIME OF OPENING FOR IMPLANTATION, SO WE DIDN¿T USE IT AND OPENED A NEW ONE. (B)(6) 2019 UPDATE VIA PHONE WITH SALES REP: THERE WAS NO DAMAGE NOTED ON THE OUTER BLISTER. THE INNER BLISTER APPEARED TO HAVE DISCOLORATION. THE IMPLANT ALSO APPEARED TO BE DISCOLORED. CASE TYPE: PKA SURGICAL DELAY: X - =15 MINUTES UPDATE: "THE IMPLANT WAS DISCOVERED AS FAULTY IMMEDIATELY UPON OPENING AND DID NOT MAKE CONTACT WITH THE PATIENT. THE SCRUB TECH DID NOT OBSERVE OR COMMENT ON ANY TEARS OR OPENINGS IN THE BLISTER PACKAGING PRIOR TO OPENING. THE BLEMISH IS ON THE CENTER OF THE IMPLANT IN THE TROCHLEAR GROOVE. IT APPEARS AS THOUGH THE METAL TARNISHED IN SOME WAY. I WAS NOT ABLE TO WIPE OR SCRAPE OFF THE BLEMISH USING A WIPE OR TOOL. IT WAS ADDITIONALLY OBSERVED WHERE THE INNER BLISTER PACKAGING WAS CONTACTING THE BLEMISH, THE PACKAGING TURNED YELLOW. RIGHT PATELLOFEMORAL MAKO"

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8691248 ↗

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-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