PHOENIX NAIL SYSTEM 14-405065Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868092695), received between Mar 24, 2021 and Jul 9, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K050118, K063570); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY EIGHTEEN MONTHS POST INITIAL SURGERY DUE TO KNEE PAIN. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. IT WAS INDICATED THAT THE PAIN WAS NOT RELATED TO THE IMPLANT, IT WAS ALLEGED ON INSTRUMENTATION AND UNCERTAIN IF IT IS RELATED TO THE PROCEDURE AND, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 12146075 ↗
• InjuryMar 24, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Discomfort; Failure of Implant; Pain

  MAUDE report 11561378 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050118, K063570. One submission often covers many models, so check the product and lot details in each record.

• Z-0627-2021 · Nov 25, 2020 · Terminated
  RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Product Usage: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthe
• Z-0625-2021 · Nov 25, 2020 · Terminated
  PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 14-405044, 14-405070 - Product Usage: Fracture fixation of small bones, small bone fragements and long b
• Z-1819-2016 · Apr 1, 2016 · Terminated
  Various trauma and sports medicine instruments and implants. Rod, fixation, intramedullary and accessories.
• Z-1478-2012 · Mar 30, 2012 · Terminated
  REF 28234 Troch Nail, Long 11MM, Right 34 CM Peritrochanteric Nail System, Rx Sterile Biomet Trauma Persippany, NJ Rod, Fixation, Intramedullary and Accessories Product Usage: An
• Z-0012-06 · Jun 24, 2005 · Terminated
  EBI Trochanteric 11mm Long Nail.