medical Class II Updated 2020-08-12

Mako Surgical Corporation recalls Mako Hip End Effector, Variable Angle Catalog Number: 20696

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Affected States: TX, MN, CA, RI, FL, NY, AZ, TN
Lot/Code Info: 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;
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