NA 03.100.017Recalls & reported problems

Synthes GmbH · MALLEABLE RETRACTOR 40MM WIDE · 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 10886982070661), 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 16, 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) MALLEABLE RETRACTOR 40MM WIDE. THIS IS REPORT 3 OF 10 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12937531 ↗

Device details

UDI-DI	`10886982070661`
Brand	NA
Model	03.100.017
Catalog no.	03100017
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
RadiaLux™ 50-101-1
Medtronic Navigation, Inc. · RETRACTOR
1 recall2 reports
Omni-Tract® 11275
Integra Lifesciences Corporation · 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® 3104R
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 16, 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