Recall Z-2745-2020— Mako Surgical Corporation

Name: FDA recall Z-2745-2020
Creator: U.S. Food and Drug Administration
Published: 2020-07-09

Class II · Terminated

Class II FDA medical device recall by Mako Surgical Corporation, initiated 2020-07-09, terminated 2023-06-16. It names one FDA 510(k) clearance: K141989. Product: Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167. Reason: Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures..

Recalling firm: Mako Surgical Corporation
Classification: Class II
Status: Terminated
Initiated: 2020-07-09
Terminated: 2023-06-16
Firm location: Davie, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K141989 — MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEMMako Surgical Corporation·cleared 2014-11-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.