U2™ Knee 9304-4102Recalls & reported problems

United Orthopedic Corp. · PS Housing punch · Class 1

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04719872175537), received between Jul 18, 2024 and Jul 18, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Break1
Detachment of Device or Device Component1
Material Deformation1
Material Separation1
No Apparent Adverse Event1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionJul 18, 2024Break; Material Separation; Detachment of Device or Device Component; Material Deformation; No Apparent Adverse Event; Break; Material Separation; Detachment of Device or Device Component; Material Deformation; No Apparent Adverse Event
THE SURGEON WAS MALLETING THE PS HOUSING PUNCH INSTRUMENT (PN: 9304-4102) INTO THE DEDICATED SLOT AS INTENDED BY SURGICAL TECHNIQUE. DURING THE FINAL HIT OF THE MALLET, THE PS HOUSING COMPONENT BROKE INTO MULTIPLE PIECES. IT OCCURRED AT THE END OF THE SURGERY AFTER THE BONE WAS ALREADY REMOVED, SO A BACKUP INSTRUMENT WAS NOT REQUIRED. ALL STAFF CAREFULLY REMOVED THE BROKEN PIECES FROM THE SURGICAL FIELD, CONFIRMING NONE FELL INTO THE SURGICAL SITE. AGENT ON SITE DURING THE SURGERY WAS INTERVIEWED AND CONFIRMED THAT THE INSTRUMENT WAS USED ACCORDING TO THE STANDARD PROCEDURE. THE BROKEN PS HOUSING PUNCH HAS BEEN DISCARDED BY THE HOSPITAL INADVERTENTLY RESULTING IN NO FURTHER ANALYSIS OR INSPECTION OF THE AFFECTED INSTRUMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19768591 ↗

Device details

UDI-DI	`04719872175537`
Brand	U2™ Knee
Model	9304-4102
Company	United Orthopedic Corp.
Product code	HWP · Punch, Femoral Neck
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 5, 2018

Device type (GMDN): Orthopaedic osteotome

A chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Other Punch, Femoral Neck devices

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Microport Orthopedics Inc. · PUNCH, FEMORAL NECK
2 reports
Lineage 20070052
Microport Orthopedics Inc. · PUNCH, FEMORAL NECK
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All Punch, Femoral Neck 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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