FDA recall Z-2745-2020

Mako Surgical Corporation · Class II · device

Product

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

Reason for recall

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

Distribution

TX, MN, CA, RI, FL, NY, AZ, TN

Key facts

Status
Terminated
Initiation date
2020-07-09
Report date
2020-08-12
Termination date
2023-06-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Davie, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2745-2020