Z-2055-2013Class II

00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before...

Name: Z-2055-2013 00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before...
Creator: Zimmer, Inc.
Published: 2013-08-01
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-08-01 / Terminated / root cause: design

FDA source

Zimmer, Inc. began a recall of 00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before use) The Glenosphere Distractor must be able to... on 2013-08-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2055-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-01
Posted: 2013-08-26
Terminated: 2015-03-02
Recalling firm: Zimmer GmbH
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.
Product code: KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
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
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 771
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 codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2055-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2055-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-26

Product code KWT

K052906Class IIZimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. / cleared 2005-12-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)