Food, drugs, devices › Mako Surgical Corporation
Device recall: Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with th
FDA enforcement event 80552 is a device recall by Mako Surgical Corporation of Davie, FL, initiated 10 May 2018 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 17 Jan 2021. Initiation: voluntary: firm initiated. Mako Surgical Corporation has 22 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Mako Surgical Corporation, Davie, FL.
Reason for recall
"Out of tolerance."
Distribution
"Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2794-2018 | Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical… | 10,606 | Class II | Terminated | 22 Aug 2018 |
Context
Other enforcement events for Mako Surgical Corporation
All 22 events for Mako Surgical Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Out of tolerance."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 17 Jan 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.