NA 71070804Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010495525), 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 WHO INITIALLY UNDERWENT PLACEMENT OF A TAYLOR SPATIAL FRAME (TSF) ON (B)(6) 2022 TO REPAIR A LEFT TIBIA NONUNION WITH AUTOGRAFT AND ALLOGRAFT, DEVELOPED A PIN SITE INFECTION IN OR AROUND (B)(6) 2022 AND WAS PLACED ON BACTRIM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Medical device site infection

  MAUDE report 21441850 ↗

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

…and 12 more.