Jet-X 71062250Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010486691), received between Jun 24, 2021 and Jan 24, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN EXTERNAL FIXATOR PLACEMENT ON (B)(6) 2021 TO STABILIZE A RIGHT ANKLE FRACTURE & DISLOCATION, THE PATIENT REQUIRED FRAME REMOVAL WITH I&D ON (B)(6) 2022 DUE TO INFECTED HARDWARE. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP (PMCF) ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Medical device site infection

  MAUDE report 21229911 ↗
• MalfunctionJun 24, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING AN EXTERNAL FIXATION, TWO (2) JET-X 250MM BAR'S CARBON FIBER HAD SPLINTERED, AND TORE THE GLOVE OF ONE OF THE SURGEON MAKING THE ADJUSTMENT. IT IS MENTIONED THAT THIS SPLINTER COULD HAVE STABBED ANYONE NEEDED TO ACCESS THIS PART OF THE CONSTRUCT, INCLUDING THE PATIENT, RESIDENT OR ATTENDING SURGEON, BUT NO ONE WAS HARMED AS CONSEQUENCE OF THIS PROBLEM. FIXATION WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12058157 ↗
• MalfunctionJun 24, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING AN EXTERNAL FIXATION, TWO (2) JET-X 250MM BAR'S CARBON FIBER HAD SPLINTERED, AND TORE THE GLOVE OF ONE OF THE SURGEON MAKING THE ADJUSTMENT. IT IS MENTIONED THAT THIS SPLINTER COULD HAVE STABBED ANYONE NEEDED TO ACCESS THIS PART OF THE CONSTRUCT, INCLUDING THE PATIENT, RESIDENT OR ATTENDING SURGEON, BUT NO ONE WAS HARMED AS CONSEQUENCE OF THIS PROBLEM. FIXATION WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12058136 ↗

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-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-1752-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 6 MM X 40 MM SHORT HALF PIN TI-6AL-4V, REF 71056408, 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-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-1763-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 5 MM X 40 MM SHORT HALF PIN TI-6AL-4V, REF 71055401, 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-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-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-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-1759-2012 · Apr 13, 2012 · Terminated
  JET-X(R) 5 MM X 20 MM SHORT HALF PIN TI-6AL-4V, REF 71055201, 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-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-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-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.

…and 4 more.