NA 249.919Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982171511), received between Nov 1, 2021 and Nov 1, 2021 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K001941); 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 16, 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.

• InjuryNov 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A HARDWARE REMOVAL FROM THEIR LEFT PELVIS AND LEFT ANKLE DUE TO PAIN. TWO (2) WASHERS WERE RETAINED IN THE PATIENT¿S PELVIS. THE SURGEON REMOVED 7.3MM CANNULATED SCREWS FROM THE PELVIS FROM THE LEFT ANKLE FOUR (4) PLATES AND 28 SCREWS WERE REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS LINKED TO (B)(4). THIS REPORT IS FOR ONE (1) 2.4MM T-PLATE 3 HOLES HEAD/ 10 HOLES SHAFT/66MM. THIS IS REPORT 3 OF 20 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12728670 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K001941. One submission often covers many models, so check the product and lot details in each record.

• Z-0406-2014 · Jul 30, 2013 · Terminated
  Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand.