Z-1550-2026Class II

Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software...

Name: Z-1550-2026 Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software...
Creator: Medartis AG
Published: 2026-01-09
License: https://open.fda.gov/license/

Medartis AG / initiated 2026-01-09 / Open, Classified / root cause: labeling and UDI

FDA source

Medartis AG began a recall of Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The... on 2026-01-09. FDA classified it as Class II and gives the reason as "Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1550-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-09
Posted: 2026-03-10
Recalling firm: Medartis AG
Product: Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Firm began notifying affected customers on January 13, 2026 via email. Customers were instructed to return impacted products to Medartis Inc.
Quantity in commerce: 126
Distribution: Worldwide - US Nationwide distribution in the states of Indiana and Pennsylvania and the countries of Austria, Belgium, Switzerland, Czech Republic, Germany, Spain, Finland, France, Israel, Italy, Japan, and Poland.
Product codes and lots: Lot Code: Version or Model: A-5850.16/1 Device Description: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Lot: 25467933

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1550-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1549-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-18	2026-03-10
Z-1550-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-18	2026-03-10

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)