UNITUS 15ZB00111Recalls & reported problems

Tyber Medical, LLC · 25Bx20Lx20R STERILE KIT · Class 2

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 00196449009015), received between Mar 7, 2024 and Mar 7, 2024 — classified as 1 malfunction.

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.

Reports received per month

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

Most reported problems

Device problems

Insufficient Device Problem Information1
Material Fragmentation1

Patient problems

Impaired Healing1
Nonunion/Delayed-union Bone Fracture1
Skin Infection1

Recent adverse event reports

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

MalfunctionMar 7, 2024Material Fragmentation; Insufficient Device Problem Information; Material Fragmentation; Insufficient Device Problem Information
HARDWARE BROKE AFTER THE 6-8 WEEKS POST OP. STAPLE FAILED TO UNIONIZE BONE POST OP. SKIN IRRITATION ONLY WHERE LARGE STAPLES WERE IMPLANTED. DEVICE STILL IMPLANTED. PATIENT TRYING A BONE STIMULATOR.
Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture; Skin Infection
MAUDE report 18860051 ↗

Device details

UDI-DI	`00196449009015`
Brand	UNITUS
Model	15ZB00111
Company	Tyber Medical, LLC
Product code	JDR · Staple, fixation, bone
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Aug 15, 2025

Device type (GMDN): General internal orthopaedic fixation system implantation kit

A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

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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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