Home/Recalls/FDA-Z-2361-2026
FDA DevicesClass II

Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannu...

Published: June 17, 2026Recall ID: Z-2361-2026Category: devicesCountry: US

Reason for Recall / Hazard

The cannulation of the CCS screw is not centered.

Product Description & Identification

Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation

Additional Source Details

FieldValue
CityBasel Town
StateN/A
Event id98952
Address 1Hochbergerstrasse 60e
Address 2N/A
Code infoUDI/DI 07630037887706, Lot Numbers: 25444702, 24425542, 24404471, 25441997
Postal codeN/A
Report date20260617
Product typeDevices
Product quantity13 units
Reason for recallThe cannulation of the CCS screw is not centered.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260424
Initial firm notificationE-Mail
Center classification date20260609

Overview

  • Recalling FirmMedartis AG
  • StatusOngoing
  • Risk LevelClass II
  • DistributionUS Nationwide distribution in the states of LA, TX. IN, CA, NC.
Official Agency Alert