Recall Z-1274-2014— Synthes, Inc.

Name: FDA recall Z-1274-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-07

Class II · Terminated

Class II FDA medical device recall by Synthes, Inc., initiated 2014-01-07, terminated 2015-09-10. It names one FDA 510(k) clearance: K113364. Product: Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna.. Reason: The Drill Template and the Saw Guide for the Ulna Osteotomy System may exhibit jamming, bending, or breaking of the screw connecting the Saw Guide to the Drill Template or jamming, bending, or breaking of the K-wire during fixation of the Drill Template..

Recalling firm: Synthes, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-01-07
Terminated: 2015-09-10
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K113364 — 2.7MM LCP ULNA OSTEOTOMY SYSTEMSynthes (USA) Products, LLC·cleared 2012-02-29

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

Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna.

Reason for recall

The Drill Template and the Saw Guide for the Ulna Osteotomy System may exhibit jamming, bending, or breaking of the screw connecting the Saw Guide to the Drill Template or jamming, bending, or breaking of the K-wire during fixation of the Drill Template.

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