ILIZAROV 103301Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 23596010032069), received between Apr 3, 2024 and Apr 3, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Nonstandard Device” (1 report).

19 other recalls cover devices cleared under the same FDA submission (K994143); 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.

Most reported problems

Recent adverse event reports

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

• MalfunctionApr 3, 2024Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT, DURING AN EXTERNAL FIXATION PROCEDURE, EIGHT (8) NUT 10MM {} NYLON INSERTS COULD NOT BE TURNED ON A BOLT WITHOUT SHEARING IT. OLD STYLE OFF WHITE/YELLOW INSERT WORKED, BUT THE NEW BRIGHT WHITE INSERT IS FAULTY. THE PROCEDURE WAS RESUMED, USING A COMPETITOR DEVICE (IDEAL MEDICAL). PROCEDURE WAS DELAYED FOR 60 MIN. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19032464 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K994143. One submission often covers many models, so check the product and lot details in each record.

• Z-1756-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 6 MM X 60 MM SHORT HALF PIN TI-6AL-4V, REF 71056608, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1750-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 6 MM X 30 MM SHORT HALF PIN TI-6AL-4V, REF 71056308, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1749-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 6 MM X 25 MM SHORT HALF PIN TI-6AL-4V, REF 71056258, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1761-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 5 MM X 30 MM SHORT HALF PIN TI-6AL-4V, REF 71055301, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1747-2012 · Apr 13, 2012 · Terminated
  JET-X(R) BAR 5 MM X 45 MM BAR SHORT HALF PIN TI-6AL-4V, REF 71055451, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1757-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 6 MM X 65 MM SHORT HALF PIN TI-6AL-4V, REF 71056658, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1762-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 5 MM X 35 MM SHORT HALF PIN TI-6AL-4V, REF 71055351, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1751-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 6 MM X 35 MM SHORT HALF PIN TI-6AL-4V, REF 71056358, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1753-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 6 MM X 45 MM SHORT HALF PIN TI-6AL-4V, REF 71056458, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1748-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 6 MM X 20 MM SHORT HALF PIN TI-6AL-4V, REF 71056208, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1754-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 6 MM X 50 MM SHORT HALF PIN TI-6AL-4V, REF 71056508, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1760-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 5 MM X 25 MM SHORT HALF PIN TI-6AL-4V, REF 71055251, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1765-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 5 MM X 55 MM SHORT HALF PIN TI-6AL-4V, REF 71055551, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1755-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 6 MM X 55 MM SHORT HALF PIN TI-6AL-4V, REF 71056558, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1758-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 6 MM X 70 MM SHORT HALF PIN TI-6AL-4V, REF 71056708, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.

…and 4 more.