NA 413.355Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982212092), received between Oct 25, 2019 and Oct 25, 2019 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K000682, K023941); 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.

• InjuryOct 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT A REVISION PROCEDURE OF A TOMOFIX OPENING WEDGE NAIL TIBIAL OSTEOTOMY DUE TO NON-UNION. ORIGINALLY, THE PATIENT WAS IMPLANTED WITH A TOMOFIX OSTEOTOMY SYSTEM ON (B)(6) 2019. THE TOMOFIX PLATE, FIVE (5) LOCKING HEAD SCREWS AND ONE (1) CORTEX SCREW WERE EXPLANTED AND A NEW PLATE AND SCREWS WERE PUT IN WITH THE SAME PLATE AND SCREWS. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY DURING REVISION. PATIENT AND PROCEDURE OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS IS 6 OF 7 FOR REPORT (B)(4).

  Patient problems: No Code Available

  MAUDE report 9241220 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000682, K023941. 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