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Open, Classified

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

FDA Recall Z-2361-2026 · Posted 2026-06-09

Recalling FirmMedartis AG
Recall StatusOpen, Classified
Product CodeHWC
Date Initiated2026-04-24
Product Quantity13 units

Reason for Recall

The cannulation of the CCS screw is not centered.

Firm Action

Medartis issued an URGENT: Field Safety Notice - Recall to its consignees on 5/4/2026 via USPS. The notice explained the problem with the device, potential risks associated with its use, intraoperatively and postoperatively, and provided postoperative patient recommendations. Response to the Field Safety Notice should be made to: [email protected] or Medartis Inc., 1195 Polk Drive Warsaw, IN 46582. The device are to be returned.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of LA, TX. IN, CA, NC.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire SystemMedartis AG · 2020-11-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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