Recall Z-1508-2016— Mako Surgical Corporation
Class II · Terminated
Class II FDA medical device recall by Mako Surgical Corporation, initiated 2014-04-30, terminated 2019-07-24. It names 2 FDA 510(k) clearances: K121064, K112507. Product: Robotic Arm Interactive Orthopedic System (RIO). Reason: Revision of the field manual.
- Recalling firm
- Mako Surgical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-30
- Terminated
- 2019-07-24
- Firm location
- Plantation, FL, United States
510(k) clearances named in this recall
2 on FDA's record- K121064 — MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM
- K112507 — RESTORIS PARTIAL KNEE APPLICATION (PKA), 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
Robotic Arm Interactive Orthopedic System (RIO)
Reason for recall
Revision of the field manual
Data sourced from openFDA. This site is unofficial and independent of the FDA.