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U.S. Department of Health and Human Services

Class 2 Device Recall Trabecular Metal" Reverse Shoulder System

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  Class 2 Device Recall Trabecular Metal" Reverse Shoulder System see related information
Date Initiated by Firm October 17, 2013
Date Posted February 24, 2014
Recall Status1 Terminated 3 on September 12, 2014
Recall Number Z-1079-2014
Recall Event ID 66430
510(K)Number K052906  
Product Classification Prosthesis, shoulder, non-constrained, metal/polymer cemented - Product Code KWT
Product Trabecular Metal" Reverse Shoulder System
Code Information 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.
Recalling Firm/
Manufacturer		 Zimmer, Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-613-6131
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWT and Original Applicant = ZIMMER, INC.
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