Recall Z-0828-2015— Mako Surgical Corporation

Name: FDA recall Z-0828-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-07

Class II · Terminated

Class II FDA medical device recall by Mako Surgical Corporation, initiated 2014-10-07, terminated 2016-10-03. It names one FDA 510(k) clearance: K121064. Product: RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.. Reason: MAKO has identified the potential that the shell impactors may be damaged intraoperatively..

Recalling firm: Mako Surgical Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-10-07
Terminated: 2016-10-03
Firm location: Plantation, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K121064 — MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEMMako Surgical Corporation·cleared 2012-06-06

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

RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.

Reason for recall

MAKO has identified the potential that the shell impactors may be damaged intraoperatively.

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