HOFFMANN 5079-6-090Recalls & reported problems

Stryker GmbH · Connecting Rod Micro · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Stryker Hoffmann connecting rod is a small bar used to link parts of an external bone fixation frame. The 24 reports describe rods cracking or crumbling after repeated cleaning, sterilization or reuse, with no deaths and no injuries mentioned. There is 1 open recall started in July 2026 about rods potentially cracking after cleaning and sterilization, with reports rising from 0 to 24.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 16
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04546540389930), received between May 28, 2026 and Aug 26, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Crack” (16 reports).

1 FDA recall record name this device's identifier, 1 still open.

6 other recalls cover devices cleared under the same FDA submission (K033476); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Recalls naming this device

Jul 1, 2026Open, Classified
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Z-2831-2026 · Root cause: Device Design · FDA record ↗

Most reported problems

Device problems

Crack16

Patient problems

No Clinical Signs, Symptoms or Conditions16

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 26, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50458140 ↗
MalfunctionAug 24, 2026Crack
It was reported that, cracks were identified in Hoffmann Micro carbon rods during inspection.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50418735 ↗
MalfunctionAug 24, 2026Crack
RA2026-4365088Cracks identified in Hoffmann Micro carbon rods.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50418729 ↗
MalfunctionAug 24, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50418722 ↗
MalfunctionAug 24, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50410156 ↗
MalfunctionAug 24, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50408168 ↗
MalfunctionAug 24, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50408164 ↗
MalfunctionAug 20, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50352530 ↗
MalfunctionAug 20, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50352524 ↗
MalfunctionAug 20, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50351522 ↗
MalfunctionAug 20, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50351519 ↗
MalfunctionMay 28, 2026Crack
AS REPORTED: "CARBON RODS SHOW VISIBLE CRACKS AFTER STERILIZATION/CLEANING (REPROCESSING)'.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25322157 ↗
MalfunctionMay 28, 2026Crack
AS REPORTED: "CARBON RODS SHOW VISIBLE CRACKS AFTER STERILIZATION/CLEANING (REPROCESSING)".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25321719 ↗
MalfunctionMay 28, 2026Crack
AS REPORTED: "CARBON RODS SHOW VISIBLE CRACKS AFTER STERILIZATION/CLEANING (REPROCESSING)'.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25321717 ↗
MalfunctionMay 28, 2026Crack
AS REPORTED: ''CARBON RODS SHOW SMALL CRACKS AND SWELLING AFTER THE FIRST CLEANING/STERILIZATION CYCLE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25318353 ↗
MalfunctionMay 28, 2026Crack
AS REPORTED: "UPON DOING INSPECTIONS FOR PQH 4135808, CRACKS WERE FOUND ON THE ENDS OF ADDITIONAL RODS NOT WITHIN THE SCOPE OF THE PRODUCT HOLD."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25317495 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033476. One submission often covers many models, so check the product and lot details in each record.

Z-2833-2026 · Jul 1, 2026 · Open, Classified
Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150.
Z-2832-2026 · Jul 1, 2026 · Open, Classified
Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120.
Z-2830-2026 · Jul 1, 2026 · Open, Classified
Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060.
Z-2829-2026 · Jul 1, 2026 · Open, Classified
Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050.
Z-2828-2026 · Jul 1, 2026 · Open, Classified
Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040.
Z-2827-2026 · Jul 1, 2026 · Open, Classified
Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.

Device details

UDI-DI	`04546540389930`
Brand	HOFFMANN
Model	5079-6-090
Company	Stryker GmbH
Product code	KTT · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
Class	Class 2
FDA submission	K033476
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 24, 2026

Device type (GMDN): External orthopaedic fixation system noninvasive component, single-use

A noninvasive, non-powered structural component of an external orthopaedic fixation system intended for bone/joint treatment (typically fracture stabilization, deformity correction, or distraction), in conjunction with an invasive bone pin (not included). It is in the form of a full or partial ring, rod (e.g., straight, curved, telescopic), plate, or connector (e.g., screw, bolt, nut, hinge, coupling, fastener); it is not a surgical instrument. This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.