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PHOENIX NAIL SYSTEM 14-444181Recalls & reported problems

Biomet Orthopedics, LLC · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887868097669), received between Jun 11, 2025 and Jun 11, 2025 — classified as 1 injury.

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

8 other recalls cover devices cleared under the same FDA submission (K072161); 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • Failure of Implant1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

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

    Patient problems: Failure of Implant

    MAUDE report 22187263 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072161. One submission often covers many models, so check the product and lot details in each record.

  • Z-2281-2009 · Apr 2, 2009 · Terminated
    TI Cann Partl Thd Recon Screw 6.00MM x 85MM; Trauma Fixation Systems, Rx Only; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 The screw devices are an internal fixation devic
  • Z-2282-2009 · Apr 2, 2009 · Terminated
    TI Cann Partl Thd Recon Screw 6.00MM x 90MM; Trauma Fixation Systems, Rx Only; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 The screw devices are an internal fixation devic
  • Z-2283-2009 · Apr 2, 2009 · Terminated
    TI Cann Partl Thd Recon Screw 6.00MM x 95MM; Trauma Fixation Systems, Rx Only; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 The screw devices are an internal fixation devic
  • Z-2280-2009 · Apr 2, 2009 · Terminated
    TI Cann Partl Thd Recon Screw 6.00MM x 80MM; Trauma Fixation Systems, Rx Only; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 The screw devices are an internal fixation devic
  • Z-2277-2009 · Apr 2, 2009 · Terminated
    TI Cann Partl Thd Recon Screw 6.00MM x 65MM; Trauma Fixation Systems, Rx Only; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 The screw devices are an internal fixation devic
  • Z-2279-2009 · Apr 2, 2009 · Terminated
    TI Cann Partl Thd Recon Screw 6.00MM x 75MM; Trauma Fixation Systems, Rx Only; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 The screw devices are an internal fixation devic
  • Z-2278-2009 · Apr 2, 2009 · Terminated
    TI Cann Partl Thd Recon Screw 6.00MM x 70MM; Trauma Fixation Systems, Rx Only; Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 The screw devices are an internal fixation devic
  • Z-2115-2009 · Mar 27, 2009 · Terminated
    Phoenix Cannulated Recon Screw; Ti-Cann PARTL THD Recon Screw Trauma Fixation Systems; Rx only Biomet Trauma, 100 Interpace Parkway, Parsippany, NJ 077054 Intended to aid in the a

Other ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES devices

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Sources and updates

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