FDA-Device2014-10-29Class II

Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained, Metal/Polymer

Zimmer, Inc.
Hazard

The affected products are missing polar boss threads.

Sold states
Worldwide Distribution: US (nationwide) in the states of : IA, CA, NC, AL, WA, FL, TN, MA, AZ, TX, UT, and NV; and Internationally to Japan.
Affected count
19
Manufactured in
1800 W Center St, Warsaw, IN, United States
Products
Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained, Metal/Polymer

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0094-2015

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