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Recall Observatory FDA recall evidence

Device product

Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167

Z-2745-2020

July 09, 2020

Class II

Product summary

Firm
Mako Surgical Corporation
Event
Event 86048
Status
Terminated
Classification
Class II
Quantity
12 units
Official record key
device-enforcement:Z-2745-2020

Official wording

Reason: Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.

Code information: UDI: (01)00848486022167(21)1905386; (01)00848486022167(21)1905389; (01)00848486022167(21)1905359; (01)00848486022167(21)1905352; (01)00848486022167(21)1905369; (01)00848486022167(21)1905387; (01)00848486022167(21)1905383; (01)00848486022167(21)1905353; (01)00848486022167(21)1905356; (01)00848486022167(21)1905357; (01)00848486022167(21)1905365; (01)00848486022167(21)1905388;

Distribution pattern: TX, MN, CA, RI, FL, NY, AZ, TN

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.