VariAx 656420Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327068863), received between Jan 3, 2020 and Feb 13, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2023Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN IN THE RIGHT FOOT AND IN THE IMPLANT. THE PATIENT HAD HARDWARE REMOVED DUE TO MECHANICAL FAILURE/MALFUNCTION OF FUSION( RIGHT FOOT). THE INITIAL DIAGNOSIS WAS PSEUDARTHROSIS AFTER FUSION OR ARTHRODESIS. THE PRE-OPERATIVE DIAGNOSIS WAS RIGHT HALLUX LIMITUS WITH NON-UNION. NON-UNION HALLUX INTERPHALANGEAL JOINT FUSION. THE PATIENT UNDERWENT REVISION RIGHT FIRST METATARSAL PHALANGEAL JOINT FUSION. RIGHT FOOT HARDWARE REMOVAL. RIGHT HALLUX ARTHROPLASTY. CALCANEAL BONE GRAFT HARVESTING.

  Patient problems: Implant Pain; Loss of Range of Motion; Nonunion/Delayed-union Bone Fracture

  MAUDE report 16362989 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OPEN REDUCTION AND INTERNAL FIXATION OF THE LEFT MIDFOOT. METALOSIS WAS OBSERVED DURING REMOVAL.

  Patient problems: Injury; Reaction

  MAUDE report 9549425 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT MIDFOOT OPEN REDUCTION + INTERNAL FIXATION + LISFRANC STABILISATION. METALLOSIS WAS OBSERVED DURING REMOVAL.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 9549265 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VARIAX FOOT PLATE METALOSIS NOTICED UPON REMOVAL ON (B)(6) 2019 BY SURGEON. IMPLANTED ON (B)(6) 2019. REMOVAL NOT FOR NON-UNION, JUST REMOVAL OF METALWARE.

  Patient problems: Injury; Reaction

  MAUDE report 9549158 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VARIAX FOOT PLATE METALOSIS NOTICED UPON REMOVAL ON (B)(6) 2019 BY SURGEON. IMPLANTED ON (B)(6) 2019. REMOVAL NOT FOR NON-UNION, JUST REMOVAL OF METALWARE.

  Patient problems: Injury; Reaction

  MAUDE report 9549081 ↗