SPATIAL FRAME 71070205Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010462329), received between Feb 8, 2021 and Feb 8, 2021 — classified as 1 injury.

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.

• InjuryFeb 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TSF CONSTRUCT HAD BEEN IMPLANTED ON (B)(6) 2020 FOR CORRECTING A DISTAL RADIUS PARTIAL GROWTH ARREST IN LEFT HAND, THE PATIENT EXPERIENCED TWO HALF-PIN TRACK INFECTIONS PROXIMALLY, WHICH RESULTED IN LOOSENING OF THE PINS AND AN OVERALL INCREASING INSTABILITY OF THE FRAME. UPON REMOVAL OF CONSTRUCT ON (B)(6) 2021, THE PHYSICIAN ALSO NOTICED 'PLAY' WHILE MANIPULATING TWO STRUTS INCLUDING THE SPATIAL FRAME STRUT X-SHORT AND THE FAST FX STRUT X-SHORT, WHICH RAISED QUESTIONING ON WHETHER THEY ARE 'STRUCTURALLY SOUND AND STABLE IN THEIR JOINTS AND INTERNAL MECHANISM'. BASED ON THE TWO HALF-PIN TRACK INFECTIONS AND THE TWO ALLEGED STRUTS, AS WELL AS X-RAYS REVEALING THAT THE OSTEOTOMY SITE WAS CLOSING AND THE DISTAL FRAGMENT WAS DEEMED CLINICALLY STABLE ENOUGH IN ITS CORRECTED POSITION, THE DECISION WAS MADE TO REMOVE THE FRAME AND FINISH THE LATTER STAGES OF HEALING IN A POP CAST. THE PROXIMAL HALF-PINS COULD BE PULLED OUT OF THE BONE WITHOUT ANY COUNTERCLOCKWISE TURNS. THE PATIENT RECOVERY IS ONGOING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 11291204 ↗

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-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-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.
• 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-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-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-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-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-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-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.
• 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.

…and 4 more.