Z-1079-2014Class II

Trabecular Metal" Reverse Shoulder System

Name: Z-1079-2014 Trabecular Metal" Reverse Shoulder System
Creator: Zimmer, Inc.
Published: 2013-10-17
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-10-17 / Terminated / root cause: design

FDA source

Zimmer, Inc. began a recall of Trabecular Metal" Reverse Shoulder System on 2013-10-17. FDA classified it as Class II and gives the reason as "As a result of complaints for disassociation of the TM Reverse Glenosphere from the Baseplate, Zimmer updated the related surgical technique and released a video to provide additional instructions to users on how to...". 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-1079-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-17
Posted: 2014-02-24
Terminated: 2014-09-12
Recalling firm: Zimmer GmbH
Product: Trabecular Metal" Reverse Shoulder System
Product code: KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Reason for recall: As a result of complaints for disassociation of the TM Reverse Glenosphere from the Baseplate, Zimmer updated the related surgical technique and released a video to provide additional instructions to users on how to properly assemble the Glenosphere to the Baseplate.
Root cause tag: design
FDA root cause: Device Design
Action: In November and December 2012 Sales staff were provided updated surgical technique and associated video to share with current customers, surgeons, and risk managers. October 17, 2013 Distributors ( via E-mail),and Risk Managers and Surgeons (via traceable courier) were sent written Urgent Recall notifications of these labeling changes. Current customers are identified through an invoice search and distribution history for the affected devices for the past 12 months, since 9/1/12.
Quantity in commerce: 73,002 units
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Germany, India, Malaysia, China, Singapore, Korea, Taiwan, and Brazil.
Product codes and lots: 61025613, 61009830, 61038635, 61031385, 61021507, 61021506, 61016907, 61009834, 61006493, 61006492, 60999239, 60993837, 60993836, 60987295, 60982839, 60982838, 60970974, 60970973, 60950253, 60964425, 60946627, 60970946, 60964426, 60943695, 60940448, 60950251, 60946624, 60940449, 60927405, 60934492, 60900542, 60927406, 60919029, 60914617, 60919028, 60900543, 60893180, 60893181, 60906211, 60887745, 60887744, 60875337, 60875336, 60868040, 60873954, 60868041, 60867386, 60867385, 60856882, 60856880, 60855532, 60852815, 60855529, 60846158, 60846157, 60840619, 60834839, 60806512, 60824952, 60820211, 60814537, 60785523, 60795705, 60792083, 60761203, 60752933, 60781096, 60776583, 60765951, 60768804, 60757206, 60747093, 60741590, 60747092, 60741589, 60738183, 60727960, 60738184, 60730072, 60730073, 60723302, 60723277, 60718989, 60712568, 60683321, 60675599, 60669310, 60674468, 105533, 60605155, 105588, 60577323, 60580942, 60572796, 60564704, 60572798, 60568536, 60568535, 60578677, 60568468, 60568467, 60568466, 60564623, 60564639, 60564628, 60564641, 60564638, 60564636, 60568470, 60564642, 60564635, 60564625, 60564621, and 60564633.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1079-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1079-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-24

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)