CONTROL 1738-30-000Recalls & reported problems

Depuy Orthopaedics, Inc. · CONTROL CABLE CABLE & SLEEVE - STAINLESS STEEL 1.8mm x 25 Inches · Class 2 · Implant

All models of CONTROL (5)

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295067740), received between Aug 16, 2018 and Aug 16, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

Insufficient Device Problem Information1

Patient problems

Unspecified Infection1

Recent adverse event reports

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

InjuryAug 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION AFTER FIRST REVISION. DOI: (B)(6) 2008 (CUP, STEM, CONTROL CABLE), DOI: (B)(6) 2016 (HEAD, LINER, HOLE ELIMINATOR). DOR: NONE REPORTED (LEFT HIP).
Patient problems: Unspecified Infection
MAUDE report 7788327 ↗

Device details

UDI-DI	`10603295067740`
Brand	CONTROL
Model	1738-30-000
Catalog no.	173830000
Company	Depuy Orthopaedics, Inc.
Product code	LRN · Wire, surgical
Class	Class 2
FDA submission	K971682
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 13, 2024

Device type (GMDN): Orthopaedic bone cerclage wire

An implantable thin metallic cord intended to be tightened with a knot to form a loop or ring around a fractured orthopaedic bone and/or stabilize an implant (typically a fixation plate) for treatment. It is not rigid (i.e., not a pin/K-wire) and not intended to be used in spinal bones. This is a single-use device.

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All Wire, surgical 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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