Food, drugs, devices › Mako Surgical Corporation
Device recall: Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended
FDA enforcement event 77950 is a device recall by Mako Surgical Corporation of Davie, FL, initiated 7 Aug 2017 and classified Class II, with 2 product records.
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. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 6 Aug 2019. 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
"Software discrepancy of not showing all the EE constants, when the screen is filled."
Distribution
"Worldwide - US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3130-2017 | Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. | 349 (US) and 78 (OUS) | Class II | Terminated | 20 Sep 2017 |
| Z-3131-2017 | Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. | 291 (US) and 66 (OUS) | Class II | Terminated | 20 Sep 2017 |
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: "Software discrepancy of not showing all the EE constants, when the screen is filled."
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 - US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Aug 2019. "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.