NA 71070818Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010495662), received between Feb 22, 2025 and Feb 22, 2025 — classified as 1 injury.

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.

• InjuryFeb 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT EXTERNAL FIXATOR PLACEMENT ON (B)(6) 2021 AS A PART OF A RIGHT TIBIA AND FIBULAR OSTEOTOMY PROCEDURE FOR MALUNION CORRECTION. FOLLOWING THIS PROCEDURE (AROUND (B)(6) 2021), THE PATIENT EXPERIENCED RECURRENT PIN SITE INFECTIONS THAT WERE TREATED WITH ANTIBIOTIC ADMINISTRATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Medical device site infection

  MAUDE report 21440903 ↗

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-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
• 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-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-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-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-1746-2012 · Apr 13, 2012 · Terminated
  6 MM X 35 MM X 200 MM HA COATED HALF PIN SST, REF 71070807, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1730-2012 · Apr 13, 2012 · Terminated
  6 MM X 15 MM X 150 MM HA COATED HALF PIN SST, REF 71070828, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1728-2012 · Apr 13, 2012 · Terminated
  4.5 MM X 40 MM X 150 MM HA COATED HALF PIN SST, REF 71070826, 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-1771-2012 · Apr 13, 2012 · Terminated
  6.0 MM DIAMETER 40 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF 71932961, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical devic
• 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-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-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-1737-2012 · Apr 13, 2012 · Terminated
  6 MM X 50 MM X 150 MM HA COATED HALF PIN, 1.6 MM CANNULATED, SST, REF 71070822, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
• Z-1726-2012 · Apr 13, 2012 · Terminated
  4.5 MM X 20 MM X 150 MM HA COATED HALF PIN SST, REF 71070824, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.

…and 12 more.