FDA-Device2025-04-23Class II
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
Conformis Inc.
Hazard
The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.
Sold states
US Nationwide distribution in the states of CA, FL, NV, TN.
Affected count
16
Manufactured in
600 Research Dr, Wilmington, MA, United States
Products
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1569-2025Don't want to check this manually?
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