RESTORISRecalls & reported problems across all models
Mako Surgical Corp. · 74 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one RESTORIS model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 182
- Deaths reported
- 0
- Injuries reported
- 127
- Recalls
- 2
We found 74 models of RESTORIS by Mako Surgical Corp. in the FDA's device registry (GUDID). Together they are named in 182 adverse event reports in the FDA's MAUDE database, received between Jul 19, 2017 and Aug 14, 2026 — classified as 127 injuries, 55 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (32 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
RESTORIS recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 10, 2023Open, Classified
Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
Z-1386-2023 · Root cause: Process change control · Recall details · FDA record ↗
- Mar 10, 2023Open, Classified
Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
Z-1385-2023 · Root cause: Process change control · Recall details · FDA record ↗
Most reported RESTORIS problems
Device problems
- Insufficient Device Problem Information32
- Loss of Osseointegration26
- Fracture25
- Adverse Event Without Identified Device or Use Problem19
- Osseointegration Problem19
- Break12
- Device Difficult to Setup or Prepare9
- Naturally Worn9
Patient problems
- Injury45
- Inadequate Osseointegration40
- Pain40
- No Consequences Or Impact To Patient33
- Insufficient Information22
- Unspecified Infection13
- Ambulation or Postural Difficulties12
- No Clinical Signs, Symptoms or Conditions12
RESTORIS models
74 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RESTORIS 170615PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall1 report
- RESTORIS 170616PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- RESTORIS 180606PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER9 reports
- RESTORIS 180614PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER9 reports
- RESTORIS 180615PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER8 reports
- RESTORIS 180704-1PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER8 reports
- RESTORIS 160405PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER7 reports
- RESTORIS 180604PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER6 reports
- RESTORIS 180605PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER6 reports
- RESTORIS 180613PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER6 reports
- RESTORIS 180602PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- RESTORIS 180603PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- RESTORIS 160430PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- RESTORIS 180503PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- RESTORIS 180505PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- RESTORIS 180514PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- RESTORIS 180616PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- RESTORIS 180703-1PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- RESTORIS 180705-2PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- RESTORIS 180707-1PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- RESTORIS 160195PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- RESTORIS 180404PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- RESTORIS 180617PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- RESTORIS 180702-1PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- RESTORIS 180705-1PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- RESTORIS 180403PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- RESTORIS 180513PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- RESTORIS 180515PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- RESTORIS 180518PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- RESTORIS 180607PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- RESTORIS 180612PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- RESTORIS 180702-2PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- RESTORIS 180703-3PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- RESTORIS 180706-1PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- RESTORIS 180701-2PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- RESTORIS 160403PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- RESTORIS 170505PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- RESTORIS 186040-03Hip, semi-constrained, cemented, metal/polymer + additive, cemented2 reports
- RESTORIS 120095Orthopedic stereotaxic instrument2 reports
- RESTORIS 180320-2PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- RESTORIS 180320-3PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- RESTORIS 180402PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- RESTORIS 180406PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- RESTORIS 180407PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- RESTORIS 180413PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- RESTORIS 180414PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- RESTORIS 180416PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- RESTORIS 180502PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- RESTORIS 180504PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- RESTORIS 180512PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- RESTORIS 180703-2PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- RESTORIS 180704-3PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- RESTORIS 180706-2PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- RESTORIS 180708-1PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- RESTORIS 180722-3PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- RESTORIS 180726-1PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- RESTORIS 180501PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- RESTORIS 180511PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- RESTORIS 180722-4PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- RESTORIS 180722-5PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- RESTORIS 180601PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- RESTORIS 180611PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- RESTORIS 180701-1PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- RESTORIS 170504PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- RESTORIS 170506PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- RESTORIS 170507PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- RESTORIS 170515PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- RESTORIS 170517PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- RESTORIS 170612PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- RESTORIS 186003-07Hip, semi-constrained, cemented, metal/polymer + additive, cemented1 report
- RESTORIS 186004-07Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
- RESTORIS 186004-08Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 report
- RESTORIS 186004-09Hip, semi-constrained, cemented, metal/polymer + additive, cemented1 report
- RESTORIS 160141PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
Recent RESTORIS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem
Due to factors such as the use of high-viscosity bone cement during implantation, the surgeon applied excessive impaction, resulting in a fracture of the tibial condyle. The procedure was completed by switching to total knee arthroplasty (TKA).
Patient problems: Bone Fracture(s)
MAUDE report 50251866 ↗InjuryApr 20, 2026Fracture; Osseointegration Problem
THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT HAD A REVISION FROM A PARTIAL KNEE TO TOTAL KNEE DUE TO A FRACTURED BASEPLATE. IT WAS NOTED THAT THE BASEPLATE WAS FRACTURED DOWN THE CENTER.
Patient problems: Inadequate Osseointegration; Insufficient Information
MAUDE report 24930509 ↗InjuryApr 1, 2026Fracture; Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: BOOKED REVISION SURGERY. PATIENT WAS EXPERIENCING PAIN AND SHOWED SOME SIGNS OF TIBIAL LOOSENING ON SPEC CT SCAN, SURGEON MENTIONED HE BELIEVES THE PATIENT EXPERIENCED A STRESS FRACTURE AFTER PRIMARY SURGERY FOR THE POTENTIAL CAUSE. IMPLANT APPEARED WELL BONDED TO THE CEMENT MANTLE DURING EXPLANTATION.
Patient problems: Inadequate Osseointegration; Pain; Periprosthetic fracture
MAUDE report 24758374 ↗InjuryMar 24, 2026Fracture; Loss of Osseointegration
THE FOLLOWING WAS REPORTED: "PKA REVISION (RESTORIS), WHEN REMOVING TIBIAL BASEPLATE WAS SNAPPED IN HALF. THE SURGEON THINKS IT SNAPPED WHEN HE REMOVED IT WITH AN OSTEOTOME BUT IS UNSURE IF WAS ALREADY CRACKED INSITU."
Patient problems: Arthritis; Inadequate Osseointegration; Insufficient Information; Pain
MAUDE report 24681661 ↗InjuryMar 24, 2026Fracture
THE FOLLOWING INFORMATION WAS PROVIDED: RESTORIS TIBIAL PROSTHESIS, 180607 #26090721, REVISED TO TKA - IMPLANT FOUND FRACTURED IN SITU, IMPLANT IN SITU APPROX 4 YEARS.
Patient problems: Insufficient Information
MAUDE report 24678566 ↗InjuryMar 24, 2026Fracture; Noise, Audible
InjuryDec 19, 2025Malposition of Device; Migration; Malposition of Device; Migration
THE PATIENT WHO HAD THE SURGERY OF MAKOMCK ON (B)(6) 2025 WILL HAVE A REVISION SURGERY ON (B)(6) 2025 DUE TO TIBIAL SUBSIDENCE.
Patient problems: Insufficient Information
MAUDE report 23851178 ↗InjuryDec 1, 2025Fracture; Fracture
REVISED AN LEFT MEDIAL MCK KNEE DUE TO TIBIAL BASEPLATE IMPLANT FRACTURE. HE REVISED TO A TOTAL KNEE. HE SAID THE PATIENT DIDN'T CLAIM TO HAVE A TRAUMATIC EVENT TO PARTICULARLY CAUSE IT.
Patient problems: Insufficient Information
MAUDE report 23680169 ↗InjuryOct 20, 2025Osseointegration Problem; Osseointegration Problem
AS REPORTED VIA MEDWATCH MW5176277: I HAD A PARTIAL KNEE REPLACEMENT IN 2023. I BEGAN HAVING INCREASED PAIN, INSTABILITY, AND A NOTICEABLE DEFORMITY IN THE KNEE WHEN IT WAS FLEXED IN THE EARLY SPRING OF 2024. A CT SCAN IN MAY SHOWED LOOSENING AND BONE LYSIS. IT QUICKLY WORSENED TO THE POINT WHERE I COULD FEEL THE KNEE JOINT SLIDING OVER MY TIBIA EVERY TIME I SHIFTED MY WEIGHT FORWARD. I HAD A REVISION TO A TOTAL KNEE REPLACEMENT IN 2024. THE OPERATIVE REPORT OF THE REVISION STATED "SIGNIFICANT POLYWEAR" AND "GROSS LOOSENING OF HER TIBIAL IMPLANT." IT WAS ALSO NOTED THAT I WAS "ACL (ANTERIOR CRUCIATE LIGAMENT) DEFICIENT" AND HAD "FULL THICKNESS CARTILAGE LOSS IN THE REMAINING COMPARTMENTS." THE PHYSICIAN'S ASSISTANT THAT ASSISTED IN THE SURGERY TOLD ME THE NEXT MORNING THAT HE LIFTED THE IMPLANT OUT WITH ONE FINGER.
Patient problems: Inadequate Osseointegration
MAUDE report 23334640 ↗InjurySep 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2024, A PHYSICIAN INFORMED SALEREP THAT A PF JOINT REPLACEMENT PATIENT WAS SCHEDULED FOR REVISION NEXT MONTH DUE TO CONTINUED PAIN.
Patient problems: Pain
MAUDE report 23167997 ↗InjurySep 15, 2025Osseointegration Problem; Osseointegration Problem
InjurySep 12, 2025Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT'S LEFT MEDIAL UNI KNEE WAS REVISED DUE TO THE TIBIAL BASEPLATE BREAKING IN HALF (NO CAUSE OR CONTRIBUTOR TO THE BREAKAGE WAS REPORTED TO THE REP). THE INSERT BECAME DAMAGED/ WARPED AS A RESULT. THE PATIENT WAS CONVERTED TO A TKA WITH STEM AND AUGMENTS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information
MAUDE report 23036275 ↗InjuryAug 28, 2025Degraded; Naturally Worn; Degraded; Naturally Worn
InjuryJul 28, 2025Degraded; Loss of Osseointegration; Degraded; Loss of Osseointegration
InjuryJul 10, 2025Fracture; Fracture
IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON OR ABOUT (B)(6) 2021 THE PATIENT UNDERWENT A MAKO ROBOTIC ASSISTED LEFT MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY. IT IS ALLEGED ON OR ABOUT (B)(6) 2022, THE TIBIAL COMPONENT HAD FRACTURED AND HE UNDERWENT A TOTAL KNEE REVISION ON (B)(6) 2022.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22468988 ↗
Other Mako Surgical Corp. products
All Mako Surgical Corp. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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