InCore LapidusRecalls & reported problems across all models
Medartis Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 2
We found 6 models of InCore Lapidus by Medartis Inc. in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Jul 20, 2018 and Jul 28, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fitting Problem” (1 report).
2 FDA recall records name at least one of these models by its device identifier.
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
InCore Lapidus 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 26, 2021Terminated
Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended
Z-1501-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 26, 2021Terminated
Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended
Z-1500-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported InCore Lapidus problems
Device problems
- Fitting Problem1
- Fracture1
- Improper or Incorrect Procedure or Method1
- Mechanical Jam1
- Physical Resistance/Sticking1
Patient problems
- No Known Impact Or Consequence To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Bone Fracture(s)1
InCore Lapidus models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- InCore Lapidus IC-LAP-28RScrew, Fixation, Bone1 recall0 reports
- InCore Lapidus IC-LAP-28LScrew, Fixation, Bone1 recall0 reports
- InCore Lapidus IC-LAP-5928RPScrew, Fixation, Bone1 report
- InCore Lapidus IC-LAP-3542Screw, Fixation, Bone1 report
- InCore Lapidus IC-LAP-3550Screw, Fixation, Bone1 report
- InCore Lapidus IC-LAP-0101LScrew, Fixation, Bone1 report
Recent InCore Lapidus adverse event reports
The 4 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 28, 2026Fracture
It was reported that initial surgery with InCore Lapidus System was performed on (b)(6) 2024.After 7 months from the initial, the surgeon found that one of the screw was fractured.Then revision surgery was performed on (b)(6) 2025 and all implants that were implanted at initial were removed.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50059130 ↗InjuryNov 1, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
A PATIENT WAS IMPLANTED WITH THE INCORE LAPIDUS SYSTEM (LEFT POST, 3.5MM X 32MM SCREW, 3.5 X 42MM SCREW). AFTER SURGERY, THE 3.5MM X 42MM SCREW BROKE AT THE JUNCTION WITH THE POST. ALL PIECES OF THE INCORE LAPIDUS SYSTEM WERE REMOVED PER THE SURGICAL TECHNIQUE. THE SURGEON USED BONE FILLER AND A PLATE AFTER REMOVING INCORE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9268802 ↗MalfunctionAug 14, 2019Fitting Problem
IT WAS REPORTED THAT THE INCORE POST WOULD NOT ACCEPT THE SCREW IN THE LOWER HOLE. THE POST WAS REMOVED, AND A SECOND POST WAS USED TO COMPLETE THE SURGERY. A SURGICAL DELAY OF 90 MINUTES WAS REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8895079 ↗MalfunctionJul 20, 2018Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking
IT WAS REPORTED THAT, DURING A LAPIDUS PROCEDURE OF THE 1ST TMT JOINT, A DRILL BIT SEIZED IN THE TARGETING GUIDE INSTRUMENT. THE TARGETING GUIDE WAS REMOVED AND DURING THE REMOVAL THE SURGEON STATED THAT THE MEDIAL CUNEIFORM FRACTURED DISTALLY INTO THE FUSION SITE. THE REMOVAL OF THE INSTRUMENT AND THE FRACTURED CUNEIFORM CAUSED A 30-MINUTE SURGICAL DELAY. THE FRACTURE WAS PLATED AS WELL AS THE LAPIDUS PROCEDURE COMPLETED WITH A TYPICAL PLATE AND SCREW APPROACH WITHOUT ANY SUBSEQUENT ISSUE.
Patient problems: Bone Fracture(s)
MAUDE report 7706540 ↗
Other Medartis Inc. products
All Medartis Inc. 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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