Z-1821-2024Class II

APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system

Name: Z-1821-2024 APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system
Creator: Medartis Inc.
Published: 2024-04-12
License: https://open.fda.gov/license/

Medartis AG / initiated 2024-04-12 / Open, Classified / root cause: manufacturing process

FDA source

Medartis Inc. began a recall of APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system on 2024-04-12. FDA classified it as Class II and gives the reason as "Screw is 16mm long instead of 22mm long". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1821-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-12
Posted: 2024-05-14
Recalling firm: Medartis AG
Product: APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Screw is 16mm long instead of 22mm long.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were sent an "URGENT: Field Safety Notice" via email and printed letter, dated 4/12/2024, notifying them of this recall event. Consignees are asked to locate and quarantine affected devices, coordinate the return of affected devices to their distributor, inform all users of the device of this recall event, and return the provided Customer Reply form with the relevant information. Customers with any questions can call Medartis at 574-241-6531 between 7:30 AM and 6:30 PM EST, Monday through Friday. Questions can also be sent via email to [email protected].
Quantity in commerce: 110 units
Distribution: Worldwide - US Nationwide distribution in the state of TX and the countries of Australia, Czech Republic, Finland, France, Germany, Poland, South Africa, & Switzerland.
Product codes and lots: Part No. A-5850.22/1; UDI-DI: 76300378022PA; Lot No. 24377397.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1821-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1821-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-22	2024-05-14

Product code HWC

K091479Class IIAptus Foot SystemMedartis AG / cleared 2009-07-13

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)