Medical device recalls Moderate risk

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

Recall date
July 9, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2745-2020
FDA classification
Class II
Brand / firm
Mako Surgical Corporation
Sold / distributed
TX, MN, CA, RI, FL, NY, AZ, TN

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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