FDA-Device2018-08-22Class II
ARCOS Modular Revision Hip System, item number 11-300814 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
ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2820-2018Don't want to check this manually?
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