NA 71070805Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010495532), received between Apr 19, 2024 and Apr 19, 2024 — classified as 1 injury.

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

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

• InjuryApr 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TSF SURGERY, THE HA PIN {} 6MM {} 30MM X 200MM BROKE, PORTION OF PIN WAS REMOVED AND A NEW HALF PIN PLACED IN A DIFFERENT LOCATION. REMAINING PORTION IS STILL INTEGRATED IN BONE. X-RAYS SHOW RETAINED PIN. IT IS UNKNOWN AT THIS POINT WHAT ACTIONS ARE GOING TO BE TAKEN. THE PATIENT'S CURRENT STATUS IS A DELAYED UNION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Nonunion/Delayed-union Bone Fracture

  MAUDE report 19142555 ↗

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-1739-2012 · Apr 13, 2012 · Terminated
  6 MM X 55 MM X 150 MM HA COATED HALF PIN SST, REF 71070812, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• 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-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-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-1738-2012 · Apr 13, 2012 · Terminated
  6 MM X 50 MM X 150 MM HA COATED HALF PIN SST, REF 71070810, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1736-2012 · Apr 13, 2012 · Terminated
  6 MM X 45 MM X 150 MM HA COATED HALF PIN SST, REF 71070835, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1729-2012 · Apr 13, 2012 · Terminated
  4.5 MM X 50 MM X 150 MM HA COATED HALF PIN SST, REF 71070827, 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-1740-2012 · Apr 13, 2012 · Terminated
  6 MM X 60 MM X 150 MM HA COATED HALF PIN SST, REF 71070814, 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-1733-2012 · Apr 13, 2012 · Terminated
  6 MM X 30 MM X 150 MM HA COATED HALF PIN SST, REF 71070804, 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-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-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-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.

…and 12 more.