FDA-Device2019-06-19Class II
Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
Conformis, Inc.
Hazard
Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants.
Sold states
Nationwide
Affected count
128
Manufactured in
600 Technology Park Dr, N/A, Billerica, MA, United States
Products
Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1775-2019Don't want to check this manually?
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