Recall Z-3182-2018— Mako Surgical Corporation
Class II · Terminated
Class II FDA medical device recall by Mako Surgical Corporation, initiated 2017-12-27, terminated 2020-12-14. It names 4 FDA 510(k) clearances: K170891, K170581, K170584 and 1 more. Product: Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include Unicondylar knee replacement and/or patellofemoral knee replacement.. Reason: Communication-connection error..
- Recalling firm
- Mako Surgical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-27
- Terminated
- 2020-12-14
- Firm location
- Davie, FL, United States
510(k) clearances named in this recall
4 on FDA's record- K170891 — Mako Partial Knee Application
- K170581 — Mako Total Knee Application
- K170584 — Mako Partial Knee Application
- K170593 — Mako Total Hip Application
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
Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include Unicondylar knee replacement and/or patellofemoral knee replacement.
Reason for recall
Communication-connection error.
Data sourced from openFDA. This site is unofficial and independent of the FDA.