Recall Z-2003-2016— Zimmer Gmbh

Name: FDA recall Z-2003-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-17

Class II · Terminated

Class II FDA medical device recall by Zimmer Gmbh, initiated 2016-05-17, terminated 2016-10-31. It names one FDA 510(k) clearance: K142403. Product: Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retroversion positioning. The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision, total or hemi shoulder arthroplasty. The system is intended to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.. Reason: In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS Humeral Rasp after initial positioning of the AS Humeral Trial Head which resulted in the whole construct of the Dome Centric with the still assembled AS Humeral Rasp taken out of the humeral canal. This could cause a delay in surgery time or the surgeon could decide to close the wound without finishing the surgery, increasing the infection risk or second use of anesthesia necessary..

Recalling firm: Zimmer Gmbh
Classification: Class II
Status: Terminated
Initiated: 2016-05-17
Terminated: 2016-10-31
Firm location: Winterthur, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K142403 — Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture SystemZimmer GmbH·cleared 2014-11-24

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

Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retroversion positioning. The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision, total or hemi shoulder arthroplasty. The system is intended to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.

Reason for recall

In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS Humeral Rasp after initial positioning of the AS Humeral Trial Head which resulted in the whole construct of the Dome Centric with the still assembled AS Humeral Rasp taken out of the humeral canal. This could cause a delay in surgery time or the surgeon could decide to close the wound without finishing the surgery, increasing the infection risk or second use of anesthesia necessary.

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