Stryker Mako Vizadisc Hip Procedure Tracking Kit — Class II medical device recall Z-2925-2018
Terminated recall by Mako Surgical Corporation, reported 2018-09-05, distributed in AK, AL, AR, AZ, CA, CO, CT, FL…. Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the pot
| Recall number | Z-2925-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mako Surgical Corporation, Davie, FL, United States |
| Recall initiated | 2018-07-24 |
| Classified | 2018-08-24 |
| Reported by FDA | 2018-09-05 |
| Terminated | 2022-10-11 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, FL, IA, ID, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI |
| Quantity | 19,906 devices |
| Lot numbers | 16354H, 17007K, 17013K, 17024K, 17035K, 17054K, 17097K, 17103H, 17124K, 17129K, 17136K, 17143K |
| Model numbers | 107130 |
Product
Stryker Mako Vizadisc Hip Procedure Tracking Kit
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2925-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.