FDA-Device2020-12-02Class II
iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.
Conformis, Inc.
Hazard
Incorrect hip components were provided in kits.
Sold states
US Distribution in CA.
Affected count
2
Manufactured in
600 Technology Park Dr, N/A, Billerica, MA, United States
Products
iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0475-2021Don't want to check this manually?
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