GENERIC Surgical Instruments 100.2023Recalls & reported problems

CTL Medical Corporation · T-Handle, Torque Limiting, 1/4" Square QC, 12 N-m · 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 00841732101326), received between Mar 14, 2019 and Mar 14, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Slipped” (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

Device Slipped1

Patient problems

Failure of Implant1

Recent adverse event reports

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

MalfunctionMar 14, 2019Device Slipped
WHEN REVIEWING POST OP X-RAY, NOTICED SET SCREWS WERE BACKING OUT- MORE INFO WILL BE PROVIDED ON CASE SPECIFIC AND TIME LINE FROM SURGERY DATE.
Patient problems: Failure of Implant
MAUDE report 8422972 ↗

Device details

UDI-DI	`00841732101326`
Brand	GENERIC Surgical Instruments
Model	100.2023
Company	CTL Medical Corporation
Product code	LXH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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	Apr 14, 2026

Device type (GMDN): Surgical instrument handle, torque-limiting

A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, typically manual rotation of a bone screw or setscrew, whilst providing a torque-limiting function to ensure that the screw is not over tightened, during an orthopaedic procedure. The device is typically made of metal/synthetic material (e.g., polysulphone) and may have a T-shaped handle grip. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable device.

Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices

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All ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 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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