FDA-Device2014-03-05Class II
Trabecular Metal" Reverse Shoulder System
Zimmer, Inc.
Hazard
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.
Sold states
Worldwide Distribution-USA (nationwide) and the countries of Germany, India, Malaysia, China, Singapore, Korea, Taiwan, and Brazil.
Affected count
73,002 units
Manufactured in
345 E Main St, Warsaw, IN, United States
Products
Trabecular Metal" Reverse Shoulder System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1079-2014Don't want to check this manually?
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