Z-2361-2026Class II

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

Name: Z-2361-2026 Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for...
Creator: Medartis AG
Published: 2026-04-24
License: https://open.fda.gov/license/

Medartis AG / initiated 2026-04-24 / Open, Classified

FDA source

Medartis AG began a recall of Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation on 2026-04-24. FDA classified it as Class II and gives the reason as "The cannulation of the CCS screw is not centered". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2361-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-24
Posted: 2026-06-09
Recalling firm: Medartis AG
Product: Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation
Product code: HWC Screw, Fixation, Bone
Reason for recall: The cannulation of the CCS screw is not centered.
FDA root cause: Under Investigation by 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.
Quantity in commerce: 13 units
Distribution: US Nationwide distribution in the states of LA, TX. IN, CA, NC.
Product codes and lots: UDI/DI 07630037887706, Lot Numbers: 25444702, 24425542, 24404471, 25441997

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2361-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2361-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-09

Product code HWC

K202589Class IIAPTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire SystemMedartis AG / cleared 2020-11-06

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)