NA 03.100.119Recalls & reported problems

Synthes GmbH · ALUMINUM HOHMANN RETRACTOR 22MM WIDE TIP · 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 10886982071163), received between Dec 6, 2021 and Dec 6, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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

Crack1
Device-Device Incompatibility1

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.

MalfunctionDec 6, 2021Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, UNABLE TO STERILIZE/ASSEMBLE THE MALLEABLE RETRACTOR. CHIPPING AND CRACKING ON INSTRUMENTS. UNABLE TO USE. THIS COMPLAINT INVOLVES TEN(10) DEVICES. THIS REPORT IS FOR (1) ALUMINUM HOHMANN RETRACTOR 22MM WIDE TIP. THIS IS REPORT 9 OF 10 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12938939 ↗

Device details

UDI-DI	`10886982071163`
Brand	NA
Model	03.100.119
Catalog no.	03100119
Company	Synthes GmbH
Product code	GAD · RETRACTOR
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	Apr 28, 2022

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.

Other RETRACTOR devices

Endo Paddle Retract 173046
Covidien LP · RETRACTOR
56 reports
Omni-Tract® 4040
Integra Lifesciences Corporation · RETRACTOR
1 recall3 reports
Omni-Tract® 11275
Integra Lifesciences Corporation · RETRACTOR
1 recall2 reports
RadiaLux™ 50-101-1
Medtronic Navigation, Inc. · RETRACTOR
1 recall2 reports
CHARNLEY 9620-04-000
Depuy International Ltd · RETRACTOR
1 recall2 reports
NA 2176-10-000
Depuy (Ireland) · RETRACTOR
51 reports
Fathom MR2-102050
Seaspine Orthopedics Corporation · RETRACTOR
1 recall1 report
Omni-Tract® 11303R
Integra Lifesciences Corporation · RETRACTOR
1 recall0 reports

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.

How reports and recalls are matched · Editorial policy · Report an error on this page