ANTHEM 2186.0211Recalls & reported problems

Globus Medical, Inc. · ANTHEM Anterior Lateral Clavicle Plate, Shallow Curve, 11 Holes, 103mm, SS · Class 2

All models of ANTHEM (27)

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 00889095959482), received between Dec 4, 2025 and Dec 4, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Fracture1

Patient problems

Nonunion/Delayed-union Bone Fracture1

Recent adverse event reports

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

InjuryDec 4, 2025Fracture; Fracture
IT WAS REPORTED THAT A PLATE BROKE AFTER IMPLANTING IN PATIENT A FEW MONTHS PRIOR.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 23719791 ↗

Device details

UDI-DI	`00889095959482`
Brand	ANTHEM
Model	2186.0211
Company	Globus Medical, Inc.
Product code	HRS · Plate, fixation, bone
Class	Class 2
FDA submission	K173166
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 19, 2024

Device type (GMDN): Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

A non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.

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All Plate, fixation, bone 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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