NA 71070823Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010507587), received between Feb 8, 2021 and Feb 8, 2021 — classified as 2 injuries.

27 other recalls cover devices cleared under the same FDA submission (K023921); 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 2 most recent of 2 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 REVEILING 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 11291206 ↗
• 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 11291199 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023921. One submission often covers many models, so check the product and lot details in each record.

• Z-1770-2012 · Apr 13, 2012 · Terminated
  6.0 MM DIAMETER 35 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF 71932953, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical devic
• Z-1744-2012 · Apr 13, 2012 · Terminated
  6 MM X 25 MM X 200 MM HA COATED HALF PIN SST, REF 71070803, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1725-2012 · Apr 13, 2012 · Terminated
  4.5 MM X 10 MM X 150 MM HA COATED HALF PIN SST, REF 71070823, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1743-2012 · Apr 13, 2012 · Terminated
  6 MM X 20 MM X 200 MM HA COATED HALF PIN SST, REF 71070801, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1768-2012 · Apr 13, 2012 · Terminated
  6.0 MM DIAMETER 25 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF 71932951, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical devic
• Z-1741-2012 · Apr 13, 2012 · Terminated
  6 MM X 65 MM X 150 MM HA COATED HALF PIN SST, REF 71070816, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1742-2012 · Apr 13, 2012 · Terminated
  6 MM X 70 MM X 150 MM HA COATED HALF PIN SST, REF 71070818, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1732-2012 · Apr 13, 2012 · Terminated
  6 MM X 25 MM X 150 MM HA COATED HALF PIN SST, REF 71070802, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1734-2012 · Apr 13, 2012 · Terminated
  6 MM X 35 MM X 150 MM HA COATED HALF PIN SST, REF 71070806, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1772-2012 · Apr 13, 2012 · Terminated
  6.0 MM DIAMETER 50 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF 71932962, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical devic
• Z-1745-2012 · Apr 13, 2012 · Terminated
  6 MM X 30 MM X 200 MM HA COATED HALF PIN SST, REF 71070805, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1769-2012 · Apr 13, 2012 · Terminated
  6.0 MM DIAMETER 30 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF 71932952, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical devic
• Z-1731-2012 · Apr 13, 2012 · Terminated
  6 MM X 20 MM X 150 MM HA COATED HALF PIN SST, REF 71070800, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1727-2012 · Apr 13, 2012 · Terminated
  4.5 MM X 30 MM X 150 MM HA COATED HALF PIN SST, REF 71070825, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1767-2012 · Apr 13, 2012 · Terminated
  5.0 MM DIAMETER 35 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF 71932948, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical devic

…and 12 more.