SPATIAL FRAME 71070220Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010291028), received between May 5, 2021 and May 10, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2021Device Markings/Labelling Problem; Naturally Worn; Device Markings/Labelling Problem; Naturally Worn

  IT WAS REPORTED THAT THE FIVE OF THE STRUT MEDIUM ARE WEARING CAUSING NUMBERS TO BE UNREADABLE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED AND IF THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797374 ↗
• MalfunctionMay 10, 2021Device Markings/Labelling Problem; Naturally Worn; Device Markings/Labelling Problem; Naturally Worn

  IT WAS REPORTED THAT THE FIVE OF THE STRUT MEDIUM ARE WEARING CAUSING NUMBERS TO BE UNREADABLE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED AND IF THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797351 ↗
• MalfunctionMay 5, 2021Device Markings/Labelling Problem; Naturally Worn; Device Markings/Labelling Problem; Naturally Worn

  IT WAS REPORTED THAT THE FIVE OF THE STRUT MEDIUM ARE WEARING CAUSING NUMBERS TO BE UNREADABLE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED AND IF THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11781344 ↗
• MalfunctionMay 5, 2021Device Markings/Labelling Problem; Naturally Worn; Device Markings/Labelling Problem; Naturally Worn

  IT WAS REPORTED THAT THE FIVE OF THE STRUT MEDIUM ARE WEARING CAUSING NUMBERS TO BE UNREADABLE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED AND IF THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11781336 ↗
• MalfunctionMay 5, 2021Device Markings/Labelling Problem; Naturally Worn; Device Markings/Labelling Problem; Naturally Worn

  IT WAS REPORTED THAT THE FIVE OF THE STRUT MEDIUM ARE WEARING CAUSING NUMBERS TO BE UNREADABLE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED AND IF THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11781305 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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.