DJO SURGICAL 804-03-035Recalls & reported problems

Encore Medical, L.P. · RSP, BASEPLATE RIM PLANER 40MM* DO NOT BUY · 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 00888912440998), received between Nov 1, 2021 and Nov 1, 2021 — classified as 1 malfunction.

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

Break1

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.

MalfunctionNov 1, 2021Break
INSTRUMENT FAILURE - REPRESENTATIVE DIDN'T HAVE THE CORRECT DISTRACTOR TO REMOVE THE 44 MM GLENOID HEAD SO THIS INSTRUMENT BROKE DURING THE REVISION SURGERY. THE THREADS REMAIN IN THE DISCARDED GLENOSPHERE, BUT THE REST OF THE INSTRUMENT WILL BE RETURNED. NO PIECES OF THE BROKEN INSTRUMENT WERE LEFT IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 12733960 ↗

Device details

UDI-DI	`00888912440998`
Brand	DJO SURGICAL
Model	804-03-035
Company	Encore Medical, L.P.
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	Oct 4, 2023

Device type (GMDN): Bone-resection orthopaedic reamer, reusable

An orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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