NA 2347-20-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024051652), received between Oct 4, 2022 and Oct 4, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K142579); 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.

• InjuryOct 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE OS REMOVAL OF INTERNAL DEVICE FIXATOR DEVICE OF BONE PROCEDURE, WHILE REMOVING CORTICAL SCREW FROM THE PATIENT BONE, THE SCREW SHAFT WAS FOUND TO BE FRACTURED. THE SCREW REMAINED IN THE PATIENT BODY. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15536387 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142579. One submission often covers many models, so check the product and lot details in each record.

• Z-0307-2020 · Oct 10, 2019 · Terminated
  Periarticular Plates - Tibial, Item Nos. 00234700304 00234700306 00234700308 00234700310 00234700312 00234700314 00234700316 00234700404 00234700406 00234700408 00234700410 0023470
• Z-0315-2020 · Oct 10, 2019 · Terminated
  PERI DIST VOLAR/DORSAL T/DORSAL DELTA RADIAL, Item Nos. 00234801303 00234801304 00234801306 00234801308 00234801310 00234801312 00234801403 00234801404 00234801406 00234801408 002