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00 4309-049-00 Trabecular Metal Reverse Shoulder… recallZ-2055-2013 · Zimmer, Inc. · initiated Aug 1, 2013

Class II Terminated All recalls posted in August 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

Zimmer sent a Urgent Medical Device Recall Notification letter August 1, 2013, and via E-mail and courier to all affected customers. The initial recall notice identified the reason for the recall, possible adverse risks and injuries and informed customers that a replacement will be available in the coming months. In addition, this letter will remind that the instrument is to be lubricated before each use and to inspect the foot. Customers are instructed to inspect any recalled product before and after use for cracks at the foot and ensure the foot is intact. Also ensure all moving parts are lubricated prior to each use according to the Recommendations for Care, Cleaning, Maintenance, and Sterilization Manual 97-5000-170-00. If you find a device which does not function properly or has a damaged foot, provide it to your Zimmer sales representative for return to Zimmer on a Product Experience Report (PER). Questions and concerns should be addressed to the Zimmer customer call center at 1-877-946-2761 between the hours of 8 a.m. and 5 p.m. EST. Phase 2: As devices become available for distribution, a 2nd letter will be sent to the distributors and risk managers. Distributors will be instructed to order replacement devices as a means of completing the affected instrument cases in circulation within their territories. Instructions for the return of devices will be included.

Recall details

Recall number
Z-2055-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Aug 1, 2013
Posted by the FDA
Aug 26, 2013
Recalling firm
Zimmer, Inc.
Quantity
771
Product code
KWT
FDA submissions
K052906
Distribution
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,

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.

Code information (models, lots, serial numbers)

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.

Other devices under the same FDA submission

34 devices cleared under K052906 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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