PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: November 5, 2014 Initiated: October 1, 2014 #Z-0150-2015

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.

Details

Recalling Firm
Medartis, Inc.
Units Affected
44
Distribution
US Nationwide Distribution in the states of WV, IL, CT, AZ, and WA.
Location
Kennett Square, PA

Frequently Asked Questions

What product was recalled?
APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular for the ulna.. Recalled by Medartis, Inc.. Units affected: 44.
Why was this product recalled?
A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of breakage of the temporary tension bolt.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 5, 2014. Severity: Moderate. Recall number: Z-0150-2015.