Recall Z-2055-2013— Zimmer, Inc.

Name: FDA recall Z-2055-2013
Creator: U.S. Food and Drug Administration
Published: 2013-08-01

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2013-08-01, terminated 2015-03-02. It names one FDA 510(k) clearance: K052906. Product: 00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before use) The Glenosphere Distractor must be able to attach, connect, or mate with the Glenosphere and remove it without dislodging or loosening the base plate from the glenoid, or damaging the glenoid. Pulling the trigger releases a weight inside the Distractor. This force is transmitted to the bottom of the glenosphere dislodging it from the base plate.. Reason: Zimmer is initiating a lot specific recall of the Trabecular Metal" Reverse Glenosphere Distractor due to the potential of the device not functioning properly should it be utilized without proper lubrication. As a result, there is a potential for the device to fail to provide impact to the Glenosphere when the trigger is pulled. In addition, there is a potential for the foot of the device to fract.

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-08-01
Terminated: 2015-03-02
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K052906 — ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEMZimmer, Inc.·cleared 2005-12-19

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

00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before use) The Glenosphere Distractor must be able to attach, connect, or mate with the Glenosphere and remove it without dislodging or loosening the base plate from the glenoid, or damaging the glenoid. Pulling the trigger releases a weight inside the Distractor. This force is transmitted to the bottom of the glenosphere dislodging it from the base plate.

Reason for recall

Zimmer is initiating a lot specific recall of the Trabecular Metal" Reverse Glenosphere Distractor due to the potential of the device not functioning properly should it be utilized without proper lubrication. As a result, there is a potential for the device to fail to provide impact to the Glenosphere when the trigger is pulled. In addition, there is a potential for the foot of the device to fract

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