Integra® UCHRARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780252368), received between Dec 5, 2024 and Dec 5, 2024 — classified as 1 malfunction.

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

4 other recalls cover devices cleared under the same FDA submission (K160811, K944463); 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.

• MalfunctionDec 5, 2024Structural Problem; Structural Problem

  A FACILITY REPORTED THAT THE SCREWS ON THE UNIVERSAL COMPACT H.R. ASSEMBLY (UCHRA) ARE SHORT AND DO NOT EVEN REACH THE EDGE OF THE FRAME WHEN SCREWED IN COMPLETELY. WHEN STARTING THE SURGERY AND FIXING THE FRAME, THE BLACK SUPPORTS OF THE SCREWS CAME LOOSE BECAUSE THEY DID NOT CARRY FAR ENOUGH. AS A RESULT, WE ALMOST COULDN¿T CONTINUE THE SURGERY. TO FINALIZE THE PROCEDURE, SCREWS FROM THE BIOTECHNICAL DEPT. WERE USED TO MOUNT THE INSTRUMENT IN A CORRECT WAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20858425 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160811, K944463. One submission often covers many models, so check the product and lot details in each record.

• Z-0025-2016 · Aug 21, 2015 · Terminated
  Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra CRW Precision Arc Stereo
• Z-2428-2012 · Aug 9, 2012 · Terminated
  Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM
• Z-2429-2012 · Aug 9, 2012 · Terminated
  Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be config
• Z-1400-2011 · Jan 12, 2011 · Terminated
  Integra Radionics HRAIM Intubation Head Ring Assembly Ref: HRAIM Head Rings serve as the general stereotactic treatment platform. Head Rings are used to provide a reference frame f