FDA-Device2018-08-22Class II

ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item number 192414. orthopedic hip prosthesis femoral stem

Zimmer Biomet, Inc.
Hazard

Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.

Sold states
US distribution to CA, GA, IL, MO, NY, and VA.
Affected count
12
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item number 192414. orthopedic hip prosthesis femoral stem

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2821-2018

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