NA 04.641.056Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034750149), received between Jan 17, 2020 and Jan 17, 2020 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K142587); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 17, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019 THAT THE PATIENT UNDERWENT THE REMOVAL OF AN ADAPTOR. WHEN THE SURGEON REMOVED THE PROXIMAL DISTAL ROD ARTICULATE, WHERE THE CONNECTION IS MADE THAT IS SUPPOSED TO BE RIGID, THE PARALLEL CONNECTOR WAS NOT HOLDING THE ROD. PATIENT STATUS AND OUTCOME WERE UNKNOWN. CONCOMITANT DEVICES: TITANIUM (TI) DISTAL EXTENSION SIZE 6/500MM RADIUS (PART: 04.641.076, LOT: 9953122, QUANTITY: 1) TI DISTRACTION LOCK (PART: 497.125, LOT: H688156, QUANTITY: 1). THIS REPORT IS FOR ONE (1) TI PROXIMAL EXTENSION SIZE 6/500MM RADIUS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9601614 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142587. One submission often covers many models, so check the product and lot details in each record.

• Z-2488-2015 · Jul 29, 2015 · Terminated
  VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic de