Gorilla Plating System P53-110-L213Recalls & reported problems

Paragon 28, Inc. · 4-Corner Plates: 2ND & 3RD, Large, Left · Class 2

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 00889795010032), received between Mar 28, 2024 and Mar 28, 2024 — 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.

Reports received per month

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

Most reported problems

Device problems

Break1

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.

MalfunctionMar 28, 2024Break; Break
IT WAS REPORTED THE PATIENT EXPERIENCED A NON-UNION, AS A RESULT A REVISION SURGERY WAS CONDUCTED. DURING THE REVISION SURGERY, THE PLATE WAS FOUND BROKEN.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 18992040 ↗

Device details

UDI-DI	`00889795010032`
Brand	Gorilla Plating System
Model	P53-110-L213
Company	Paragon 28, Inc.
Product code	HRS · Plate, fixation, bone
Class	Class 2
FDA submission	K140397
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 22, 2025

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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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