Food, drugs, devices › Mako Surgical Corporation
Device recall: Stryker Mako Vizadisc Knee Procedure Tracking Kit
Mako Surgical Corporation (Davie, FL) initiated this device recall on 24 Jul 2018; FDA lists 2 product records under event 80621, classified Class II.
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 11 Oct 2022. 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
"Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera."
Distribution
"All devices were distributed in the US in the following states: AK, AL, AR, AZ, CA, CO, CT, FL, IA, ID, KS, KY, LA, MA, MD, MI, MN, MO, NE, NC, NH, NJ, NY, NV, OH, PA, RI, SC, SD, TN. TX, UT, VA,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2924-2018 | Stryker Mako Vizadisc Knee Procedure Tracking Kit | 19,906 total devices | Class II | Terminated | 5 Sep 2018 |
| Z-2925-2018 | Stryker Mako Vizadisc Hip Procedure Tracking Kit | 19,906 total devices | Class II | Terminated | 5 Sep 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: "Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera."
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: "All devices were distributed in the US in the following states: AK, AL, AR, AZ, CA, CO, CT, FL, IA, ID, KS, KY, LA, MA, MD, MI, MN, MO, NE, NC, NH, NJ, NY, NV, OH, PA, RI, SC, SD, TN. TX, UT, VA,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 11 Oct 2022. "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.