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HOFFMANN 5079-6-120Recalls & 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 II Carbon connecting rod, a small bone fixation rod used in fracture repair, is the subject of 35 adverse event reports filed between May and August 2026, with no deaths or injuries described. The reports describe cracks found in the rod, in some cases noticed only after inspection. One open recall began in July 2026 because these rods may crack after cleaning and sterilization.

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
23
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04546540389947), received between May 28, 2026 and Aug 28, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Crack” (23 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 3 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 20 reportsSep 2026: 0 reportsOct 2026: 0 reports20242025202620
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Jul 1, 2026Open, Classified

    Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

    Z-2832-2026 · Root cause: Device Design · FDA record ↗

Most reported problems

Device problems

  • Crack23

Patient problems

  • No Clinical Signs, Symptoms or Conditions23

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 28, 2026Crack

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50502220 ↗
  • MalfunctionAug 28, 2026Crack

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50502219 ↗
  • MalfunctionAug 28, 2026Crack

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50502215 ↗
  • MalfunctionAug 28, 2026Crack

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50502210 ↗
  • MalfunctionAug 27, 2026Crack

    It was reported that, cracks were seen on the product after inspection.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50478701 ↗
  • MalfunctionAug 27, 2026Crack

    It was reported that, cracks were seen on the product after inspection.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50478243 ↗
  • MalfunctionAug 27, 2026Crack

    As reported: "Cracks identified in Hoffmann Micro carbon rods."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50476263 ↗
  • MalfunctionAug 26, 2026Crack

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50459568 ↗
  • MalfunctionAug 24, 2026Crack

    Cracks identified in Hoffmann Micro carbon rods.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50418751 ↗
  • 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 50418749 ↗
  • MalfunctionAug 24, 2026Crack

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50418748 ↗
  • MalfunctionAug 24, 2026Crack

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50418743 ↗
  • MalfunctionAug 24, 2026Crack

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50418728 ↗
  • MalfunctionAug 24, 2026Crack

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50418714 ↗
  • MalfunctionAug 24, 2026Crack

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50418713 ↗
  • MalfunctionAug 24, 2026Crack

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50418712 ↗
  • MalfunctionAug 24, 2026Crack

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50418709 ↗
  • MalfunctionAug 24, 2026Crack

    It was reported that the rods are cracked.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50408170 ↗
  • MalfunctionAug 24, 2026Crack

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50408166 ↗
  • MalfunctionAug 20, 2026Crack

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50351528 ↗
  • MalfunctionMay 28, 2026Crack

    AS REPORTED: "CARBON RODS SHOW VISIBLE CRACKS AFTER STERILIZATION/CLEANING (REPROCESSING)".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25321955 ↗
  • MalfunctionMay 28, 2026Crack

    IT WAS REPORTED THAT THE REPLACEMENT DELIVERY OF THE CARBON RODS WERE RECEIVED. THEY WERE PROCESSED ONCE IN THE REPROCESSING/STERILIZATION UNIT FOR MEDIZINPRODUKTE (AEMP (AUFBEREITUNGSEINHEIT FOR MEDIZINPRODUKTE)), UNFORTUNATELY THE CARBON RODS BROKE AGAIN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25321524 ↗
  • 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 25318337 ↗

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-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.
  • Z-2833-2026 · Jul 1, 2026 · Open, Classified
    Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150.
  • 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-2831-2026 · Jul 1, 2026 · Open, Classified
    Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.

Other APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT devices

All APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT devices →

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