Recall Z-0224-2016— Mako Surgical Corporation
Class II · Terminated
Class II FDA medical device recall by Mako Surgical Corporation, initiated 2015-07-16, terminated 2016-12-14. It names 2 FDA 510(k) clearances: K121064, K112507. Product: Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacement procedures.. Reason: The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector..
- Recalling firm
- Mako Surgical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-07-16
- Terminated
- 2016-12-14
- 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 (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacement procedures.
Reason for recall
The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.
Data sourced from openFDA. This site is unofficial and independent of the FDA.