NA 413.370Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982212122), received between Jun 16, 2021 and Jun 16, 2021 — 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.

• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2015 THE PATIENT UNDERWENT A STABILIZATION AND FIXATION OF FRACTURES FOLLOWING A STREET ACCIDENT. THERE WERE NO PROBLEMS IMMEDIATELY POST-OP. THE PATIENT HAD PAIN AND ON (B)(6) 2016 IT WAS OBSERVED THAT THE FRACTURES HAD NOT CONSOLIDATED. IT WAS ADVISED TO REMOVE THE IMPLANTS USED FOR THE FIXATION OF THE FRACTURES AND UNDERGO AN ARTHROSCOPY OF THE KNEE. THE POSITION OF THE FRACTURE FRAGMENTS WERE FOUND TO BE IN A GOOD POSITION. THERE WAS LOCAL INGROWTH OF SCAR TISSUE AND IRREGULARITY OF THE TIBIAL SURFACES, HOWEVER THERE WERE NO MENISCAL LESIONS AND INTACT CRUCIATE LIGAMENTS. THERE WERE NO SIGNS OF ADVERSE REACTIONS AGAINST THE IMPLANTED METAL MATERIAL. FROM 2016 THE PATIENT WAS TREATED WITH HIGH DOSES OF ARCOXIA AND PALEXIA FOR THE SERIOUS PAIN IN THE LEFT KNEE AND RIGHT HIP. THIS REPORT IS FOR (1) 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 70MM. THIS IS REPORT 10 OF 10 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 12011975 ↗

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