PHOENIX NAIL SYSTEM 14-405034Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887868092534), received between Nov 21, 2025 and Nov 21, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Biocompatibility” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT A PATIENT HAD AN INITIAL PLATE AND NAIL SYSTEM PROCEDURE. THREE MONTHS POSTOPERATIVELY, ECZEMA DEVELOPED AROUND THE SURGICAL SITE, RAISING SUSPICION OF METAL ALLERGY. CONSEQUENTLY, ALL IMPLANTS WERE REMOVED. THE PATIENT IS LIKELY A POTENTIAL CARRIER OF METAL ALLERGIES. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction; Rash

  MAUDE report 23618032 ↗

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.