D-RAD SMART PACK 74682414Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556394847), received between May 11, 2021 and May 11, 2021 — classified as 1 injury.

4 other recalls cover devices cleared under the same FDA submission (K132296, K210837, K213126); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, AFTER PLACING THE D-RAD TI 2.4MM X 14MM CTX SCR T7 S-T HAD TO BE CHANGED TO A SHORTER 12MM ONE AFTER SEEING IT UNDER THE X-RAY AS IT LOOKED VERY LONG. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805754 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132296, K210837, K213126. One submission often covers many models, so check the product and lot details in each record.

• Z-1317-2018 · Mar 7, 2018 · Terminated
  D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T LOCKING SCREW, REF 74692410, QTY (1), STERI
• Z-1857-2017 · Mar 9, 2017 · Terminated
  D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: (a) 2.4MM X 10MM, RES 74692410 (b) 2.4MM X 12MM, RES 74692412 (c) 2.4MM X 16MM, RES 74692416 (d) 2.4MM
• Z-1855-2017 · Mar 9, 2017 · Terminated
  D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic
• Z-1856-2017 · Mar 9, 2017 · Terminated
  D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Orthopedic