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RecallWatchMedical Device Safety
Device type

Bone Fixation Screw recalls

The FDA has posted 6 enforcement recalls of bone fixation screw devices since 2025, none of them Class I (most serious). Most recent report: Jun 17, 2026.

Class II: 6

Who is recalling these devices

Latest recalls

View all 6 in the recall browser →
Class IIOngoingZ-2361-2026

Medartis AG recalls Medartis APTUS

The cannulation of the CCS screw is not centered.

  • Bone Fixation Screw
  • Under Investigation by firm
Medartis AGJun 17, 2026
Class IIOngoingZ-1606-2026

I.T.S. GmbH recalls HCS - Headless Compression Screw System

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

  • Bone Fixation Screw
  • No Marketing Application
I.T.S. GmbHApr 1, 2026

Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Screw, Fixation, Bone”). Informational only — verify against the FDA before acting.