Home / Recalls / Medical Devices
Conformis, Inc. recalls iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right
Recalled October 16, 2019 · FDA recall Z-0064-2020 · Conformis
Hazard
Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging. · FDA Class II
Units
1
Sold at
Distributed to consignees in MD and NV.
Description
Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
Product
iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right
Manufacturer(s)
Conformis, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →