Recall Z-0150-2015— Medartis, Inc.

Name: FDA recall Z-0150-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-01

Class II · Terminated

Class II FDA medical device recall by Medartis, Inc., initiated 2014-10-01, terminated 2015-08-06. It names one FDA 510(k) clearance: K141232. 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.. Reason: A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of breakage of the temporary tension bolt..

Recalling firm: Medartis, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-10-01
Terminated: 2015-08-06
Firm location: Kennett Square, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K141232 — APTUS ULNA SHORTENING 2.5Medartis AG·cleared 2014-06-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular for the ulna.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.