Recall Z-1124-2017— Synthes (USA) Products LLC

Name: FDA recall Z-1124-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-29

Class II · Terminated

Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2016-12-29, terminated 2018-02-06. It names one FDA 510(k) clearance: K112030. Product: Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head.. Reason: There is the possibility that the radial stem may loosen post-operatively at the stem bone interface..

Recalling firm: Synthes (USA) Products LLC
Classification: Class II
Status: Terminated
Initiated: 2016-12-29
Terminated: 2018-02-06
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K112030 — SYNTHES RADIAL HEAD PROSTHESIS SYSTEMSynthes USA, LLC·cleared 2012-06-19

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

Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head.

Reason for recall

There is the possibility that the radial stem may loosen post-operatively at the stem bone interface.

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