FDA-Device2019-10-16Class II
iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
Conformis, Inc.
Hazard
Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
Sold states
Distributed to consignees in MD and NV.
Affected count
1
Manufactured in
600 Technology Park Dr, N/A, Billerica, MA, United States
Products
iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0063-2020Don't want to check this manually?
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