NA 71070806Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010495549), received between Feb 22, 2025 and Feb 22, 2025 — classified as 3 injuries.

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 3 most recent of 3 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) 2016 TO TREAT AN OPEN TIBIA FRACTURE AND BONE GRAFTING SUBSEQUENTLY DEVELOPED NONUNION ON (B)(6) 2016. THE PATIENT WAS UNABLE TO TOLERATE PRIOR ATTEMPTS AT TREATMENT FOR HIS NONUNION AND WAS INCONSISTENT WITH HIS ABILITY TO FOLLOW UP OR CARE FOR HIMSELF. CONSIDERING HE HAD ALSO SEVERE DEFORMITY OF THE LEFT FOOT FROM PRIOR TRAUMA, AMPUTATION OF THE LEFT LOWER EXTREMITY WAS RECOMMENDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21441858 ↗
• InjuryFeb 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT, A PATIENT WITH LEFT CHARCOT ANKLE UNDERWENT TSF (TAYLOR SPATIAL FRAME) EXTERNAL FIXATOR PLACEMENT ON (B)(6) 2019. FOLLOWING THIS PROCEDURE, THE PATIENT RETURNED TO THE OR ON (B)(6) 2019 FOR REVISION OF THE EXTERNAL FIXATOR DUE TO BROKEN PINS (UNKNOWN QUANTITY) WITH SUBSEQUENT LOOSENING OF THE WHOLE FRAME. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 21440905 ↗
• InjuryFeb 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT SUSTAINED NONUNION OF A LEFT TIBIAL FRACTURE THAT REQUIRED PLACEMENT OF A TSF (TAYLOR SPATIAL FRAME) ON (B)(6) 2022. FOLLOWING THIS PROCEDURE, THE PATIENT SUSTAINED A PIN SITE INFECTION THAT REQUIRED EXCHANGE OF ONE PIN ON (B)(6) 2022. DURING THIS PROCEDURE, A FORMAL IRRIGATION AND DEBRIDEMENT OF THE PIN SITE WAS PERFORMED AND THE EXISTING FRAME WAS BOLSTERED WITH ADDITIONAL FIXATION IN THE DISTAL LOCKING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Medical device site infection

  MAUDE report 21440898 ↗

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-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-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-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-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-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-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.
• 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-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-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-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-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-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-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.

…and 12 more.