ORTHOMAP 6003-655-000Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · ORTHOMAP¿ PRECISION KNEE 5.0 SOFTWARE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540717443), received between Feb 21, 2019 and Oct 23, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Image Display Error/Artifact” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Image Display Error/Artifact1
- Imprecision1
- Incorrect Measurement1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 23, 2025Incorrect Measurement; Incorrect Measurement
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 0 EVENTS FOR THE FAILURE: INCORRECT MEASUREMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23369346 ↗MalfunctionFeb 26, 2020Imprecision; Imprecision
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE SOFTWARE SHOWED AN INACCURACY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 9756629 ↗MalfunctionFeb 21, 2019Image Display Error/Artifact; Image Display Error/Artifact
IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE SOFTWARE SHOWED AN INACCURACY OF IMPLANT PLACEMENT, WHILE FINAL X-RAYS WERE ABLE TO VERIFY THE IMPLANT PLACEMENT WAS ACCURATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8357831 ↗
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- NA 209063Mako Surgical Corp. · Orthopedic stereotaxic instrument2 recalls602 reports
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- REAL INTELLIGENCE ROB10013Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall528 reports
- VELYS 4515-70-105Depuy (Ireland) · Orthopedic stereotaxic instrument578 reports
- VELYS 4515-70-106Depuy (Ireland) · Orthopedic stereotaxic instrument564 reports
- NA 209999Mako Surgical Corp. · Orthopedic stereotaxic instrument522 reports
- Mazor X System TPL0059-06Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument2 recalls2 deaths392 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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