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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Product Detail

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.
Recall Number Z-2055-2013
Classification Class II
Code Info Item # 00-4309-049-00 and Lot Numbers: 60452884, 60461858, 60531990, 60549559, 60605842, 60612781, 60684768, 60754281, 60815778, 60909547, 60959086, 60978338, 61029048, 61135953, 61213252, 61274877, 61334929, 61431672, 61566464, 61594740, 61690097, 61756058, 61857748, 61858851, 61889174, 61906350, 61910781, 61918666 62039450, 62096379, 62101249, 62141887, 62160965, 62215378, 62254111, 62269856, 62304206, and 62311096.
Product Distributed Qty 771
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 fracture during use which may result in the device being unable to remove the Glenosphere. There have been 17 reported complaints of the device failing to provide impact and 8 reported complaints of the foot fracturing. In the U.S.,these devices were distributed between March 13, 2006 and March 22, 2013.

Event Detail

Event Id 65677
Product Type Devices
Status Ongoing
Recalling Firm Zimmer, Inc.
City Warsaw
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-01
Initial Firm Notification of Consignee or Public
Distribution Pattern Worldwide Distribution - USA (nationwide) including the countries of Singapore, Brazil, Taiwan, Australia, Canada, Germany(with further distribution to UAE, Austria, Belgium, Switzerland, Czech Republic, Denmark, Spain, Finland, France, Greece, Israel, Italy, Malta, Norway, Portugal, Sweden and South Africa,
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