HOFFMANN 5079-6-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04546540389916), received between May 28, 2026 and Aug 27, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Crack” (14 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.

Recalls naming this device

1. Jul 1, 2026Open, Classified

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

   Z-2829-2026 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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 50478726 ↗
• 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 50478723 ↗
• 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 50478687 ↗
• 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 50478659 ↗
• MalfunctionAug 27, 2026Crack

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50476591 ↗
• MalfunctionAug 26, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50456972 ↗
• MalfunctionAug 24, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50418731 ↗
• MalfunctionAug 24, 2026Crack

  It was reported that, the visible cracks on Hoffmann II Carbon Connecting rods were seen during inspection.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50418723 ↗
• MalfunctionAug 24, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50418426 ↗
• MalfunctionMay 28, 2026Crack

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25322156 ↗
• MalfunctionMay 28, 2026Crack

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25321925 ↗
• MalfunctionMay 28, 2026Crack

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25321920 ↗
• 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 25317497 ↗
• 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 25317488 ↗

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-2830-2026 · Jul 1, 2026 · Open, Classified
  Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060.
• Z-2832-2026 · Jul 1, 2026 · Open, Classified
  Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120.
• Z-2833-2026 · Jul 1, 2026 · Open, Classified
  Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150.
• Z-2831-2026 · Jul 1, 2026 · Open, Classified
  Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.