Recall Z-1411-2017— Mako Surgical Corporation
Class II · Terminated
Class II FDA medical device recall by Mako Surgical Corporation, initiated 2016-12-22, terminated 2019-08-06. It names 2 FDA 510(k) clearances: K141989, K121064. Product: MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.. Reason: Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides.
- Recalling firm
- Mako Surgical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-12-22
- 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
MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
Reason for recall
Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides
Data sourced from openFDA. This site is unofficial and independent of the FDA.