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Recall Observatory FDA recall evidence

Device product

restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System

Z-1569-2025

March 25, 2025

Class II

Product summary

Firm
Conformis Inc.
Event
Event 96606
Status
Ongoing
Classification
Class II
Quantity
16
Official record key
device-enforcement:Z-1569-2025

Official wording

Reason: 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.

Code information: Model Number: HDL-060-C22L-000101 UDI-DI: M572HDL060C22L011. Lot: 1788258

Distribution pattern: US Nationwide distribution in the states of CA, FL, NV, TN.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incorrect labeling