Z-0150-2015Class II

APTUS Ulna Shortening 2.5

Name: Z-0150-2015 APTUS Ulna Shortening 2.5
Creator: Medartis, Inc.
Published: 2014-10-01
License: https://open.fda.gov/license/

Medartis AG / initiated 2014-10-01 / Terminated / root cause: manufacturing process

FDA source

Medartis, Inc. began a recall of APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular for the ulna on 2014-10-01. FDA classified it as Class II and gives the reason as "A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of breakage of the temporary tension bolt". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0150-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-01
Posted: 2014-10-30
Terminated: 2015-08-06
Recalling firm: Medartis AG
Product: APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular for the ulna.
Product code: HWC Screw, Fixation, Bone
Reason for recall: A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of breakage of the temporary tension bolt.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The recall is being extended to end user level of distribution. The sales representatives, customers and a distributor were notified via phone or email on September 19th and notified of the recall via US mail on 10/1/14. US customers, distributors, and sales representatives were instructed to return the affected instrument kits to the importer Medartis, Inc. via transport agency.
Quantity in commerce: 44
Distribution: US Nationwide Distribution in the states of WV, IL, CT, AZ, and WA.
Product codes and lots: Part no. A-2791.05, lot no. 14125026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0150-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0150-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-05	2014-10-30

Product code HWC

K141232Class IIAptus Ulna Shortening 2.5Medartis AG / cleared 2014-06-23

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)