TOMOFIX 440.843Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982220714), received between Oct 29, 2020 and Oct 29, 2020 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K023941, K141796); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionOct 29, 2020Use of Device Problem; Use of Device Problem

  ADDITIONAL EVENT INFORMATION THERE WAS A DELAY IN SURGERY OF MORE THAN 60 MINUTES. THE SURGERY CAN BE COMPLETED AFTER THE PROBLEM IS RESOLVED. THE PROCEDURE WAS PERFORMED SATISFACTORILY AND WITHOUT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10757168 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023941, K141796. One submission often covers many models, so check the product and lot details in each record.

• Z-0473-2014 · Oct 9, 2013 · Terminated
  Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and