Innomed, Inc. 4558-RRecalls & reported problems

Innomed, Inc. · Hohmann Retractor Ortholucent 16mm · Class 1

Data updated Oct 18, 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 00840277118981), received between Apr 11, 2022 and Apr 11, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 18, 2026.

Most reported problems

Device problems

Material Twisted/Bent1

Patient problems

Insufficient Information1

Recent adverse event reports

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

MalfunctionApr 11, 2022Material Twisted/Bent; Material Twisted/Bent
FOR A FRACTURED LEFT HIP, A HOHMANN RETRACTOR WQAS USEF. THE TIP WS WEAK AND IT BENT. THIS WAS A RADIOLUCENT RETRACTOR, A KIND THAT IS NOT NORMALLY KEPT IN THE HIP SET.
Patient problems: Insufficient Information
MAUDE report 14074311 ↗

Device details

UDI-DI	`00840277118981`
Brand	Innomed, Inc.
Model	4558-R
Company	Innomed, Inc.
Product code	GAD · Retractor
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 11, 2020

Device type (GMDN): Hand-held surgical retractor, reusable

A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

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All Retractor 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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