NA 243.234Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982169037), received between Apr 19, 2022 and Apr 19, 2022 — 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.

• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 12 OF 12 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER THAT POSTOPERATIVELY TO AN UNKNOWN SURGERY ON (B)(6) 2021, THE PATIENT UNDERWENT A DEVICE REMOVAL ON (B)(6) 2022 IN THE RIGHT ANKLE DUE TO PAIN. IT WAS REPORTED THAT ALL IMPLANTS WERE REMOVED SUCCESSFULLY AND WITHOUT COMPLICATION. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 2.0 T-PL 3 HOLES HEAD/ 10 HOLES SHAFT/65 DEVICE. THIS COMPLAINT INVOLVES 12 DEVICES.

  Patient problems: Pain

  MAUDE report 14148120 ↗

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.