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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