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Trabecular Metal" Reverse Shoulder System recallZ-1079-2014 · Zimmer, Inc. · initiated Oct 17, 2013

Class II Terminated All recalls posted in February 2014

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

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.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1079-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 17, 2013
Posted by the FDA
Feb 24, 2014
Recalling firm
Zimmer, Inc.
Quantity
73,002 units
Product code
KWT
FDA submissions
K052906
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Germany, India, Malaysia, China, Singapore, Korea, Taiwan, and Brazil.

Product description

Trabecular Metal" Reverse Shoulder System

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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.

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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