Recall Z-3131-2017— Mako Surgical Corporation
Class II · Terminated
Class II FDA medical device recall by Mako Surgical Corporation, initiated 2017-08-07, terminated 2019-08-06. It names 2 FDA 510(k) clearances: K141989, K121064. Product: Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.. Reason: Software discrepancy of not showing all the EE constants, when the screen is filled..
- Recalling firm
- Mako Surgical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-08-07
- Terminated
- 2019-08-06
- Firm location
- Davie, FL, United States
510(k) clearances named in this recall
2 on FDA's record- K141989 — MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM
- K121064 — MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM
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
Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
Reason for recall
Software discrepancy of not showing all the EE constants, when the screen is filled.
Data sourced from openFDA. This site is unofficial and independent of the FDA.