Mako Surgical Corporation: Medical Device Recall in 2020 - (Recall #: Z-2745-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 9, 2020

Date Posted: August 12, 2020

Recall Number: Z-2745-2020

Event ID: 86048

Reason for Recall:

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

Status: Terminated

Product Quantity: 12 units

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

Voluntary or Mandated:

Voluntary: Firm initiated