Trabecular Metal" Reverse Shoulder System
FDA Recall Z-1079-2014 · Posted 2014-02-24
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Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeKWT
Date Initiated2013-10-17
Date Terminated2014-09-12
Product Quantity73,002 units
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Germany, India, Malaysia, China, Singapore, Korea, Taiwan, and Brazil.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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