PHALINX 45301002Recalls & reported problems

Wright Medical Technology, Inc. · Class 2 · Implant

All models of PHALINX (10)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 7
Deaths reported: 0
Injuries reported: 7
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00840420166036), received between Mar 6, 2024 and May 27, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem5
Device Dislodged or Dislocated2
Mechanical Jam2

Patient problems

Insufficient Information5
Implant Pain1
Pain1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED RWE REPORT NAMED "SAFETY AND PERFORMANCE OF THE PHALINX IMPLANTS UTILIZING THE PREMIER HEALTHCARE DATABASE" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF PHALINX. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN (B)(6) 2016 ¿ (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, PATIENT (B)(6) HAD IMPLANT PAIN.
Patient problems: Implant Pain
MAUDE report 25299258 ↗
InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED RWE REPORT NAMED "SAFETY AND PERFORMANCE OF THE PHALINX IMPLANTS UTILIZING THE PREMIER HEALTHCARE DATABASE" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF PHALINX. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN (B)(6) 2016 ¿ (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, PATIENT 19 HAD GENERALIZED PAIN.
Patient problems: Pain
MAUDE report 25299080 ↗
InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED RWE REPORT NAMED "SAFETY AND PERFORMANCE OF THE PHALINX IMPLANTS UTILIZING THE PREMIER HEALTHCARE DATABASE" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF PHALINX. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN (B)(6) 2016 ¿ (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, PATIENT (B)(6) HAD DEVICE REVISION OR REPLACEMENT.
Patient problems: Insufficient Information
MAUDE report 25299063 ↗
InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED RWE REPORT NAMED "SAFETY AND PERFORMANCE OF THE PHALINX IMPLANTS UTILIZING THE PREMIER HEALTHCARE DATABASE" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF PHALINX. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN (B)(6) 2016 ¿ (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, PATIENT (B)(6) HAD DEVICE REVISION OR REPLACEMENT
Patient problems: Insufficient Information
MAUDE report 25299060 ↗
InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED RWE REPORT NAMED "SAFETY AND PERFORMANCE OF THE PHALINX IMPLANTS UTILIZING THE PREMIER HEALTHCARE DATABASE" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF PHALINX. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN (B)(6) 2016 ¿ (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, PATIENT 1 HAD DEVICE REVISION OR REPLACEMENT
Patient problems: Insufficient Information
MAUDE report 25299057 ↗
InjuryMar 6, 2024Device Dislodged or Dislocated; Mechanical Jam; Device Dislodged or Dislocated; Mechanical Jam
IT WAS REPORTED THAT THE IMPLANT WAS RIPPED OUT OF THE PATIENTS BONE DURING REMOVAL OF THE HANDLE IN A HAMMERTOE SURGERY. THE IMPLANT WAS STILL USED IN THE PATIENT BUT WITH LESS BONE PURCHASE.
Patient problems: Insufficient Information
MAUDE report 18852160 ↗
InjuryMar 6, 2024Device Dislodged or Dislocated; Mechanical Jam; Device Dislodged or Dislocated; Mechanical Jam
IT WAS REPORTED THAT THE IMPLANT WAS RIPPED OUT OF THE PATIENTS BONE DURING REMOVAL OF THE HANDLE IN A HAMMERTOE SURGERY. THE IMPLANT WAS STILL USED IN THE PATIENT BUT WITH LESS BONE PURCHASE.
Patient problems: Insufficient Information
MAUDE report 18852156 ↗

Device details

UDI-DI	`00840420166036`
Brand	PHALINX
Model	45301002
Company	Wright Medical Technology, Inc.
Product code	HWC · Screw, fixation, bone
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 6, 2025

Device type (GMDN): Phalangeal joint arthrodesis implant

A small, non-bioabsorbable, implantable device of fixed-length designed to be inserted within a phalangeal joint (i.e., not a plate) in the finger and/or toe (i.e., interphalangeal or phalangeal/metacarpal/metatarsal) to fuse the joint (arthrodesis), typically to manage arthritis or deformities (e.g., hammer toe), or for arthroplasty revision; it is not intended for carpal, tarsal or ankle implantation. It is typically made of metal and can be of several small designs (e.g., rod with barbs at each end, X-shaped, single or dual screw), however it is not intended to be fixed into bone with bone screws (i.e., not an intramedullary nail).

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All Screw, fixation, bone devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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