CLASS II Device recall · Reported 5 Sep 2018 · FDA Enforcement Report
Stryker Mako Vizadisc Hip Procedure Tracking Kit recalled
Mako Surgical is recalling Stryker Mako Vizadisc Hip Procedure Tracking Kit, distributed in 35 states. The recall was initiated on 24 Jul 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2925-2018
- FDA event ID
- 80621
- Recalling firm
- Mako Surgical, Davie, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jul 2018
- FDA classified
- 24 Aug 2018
- Reported
- 5 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 24 Jul 2018 | Recall initiated by company | |
| 24 Aug 2018 | Classified by FDA | +31 days |
| 5 Sep 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Stryker Mako Vizadisc Hip Procedure Tracking Kit
Where it was distributed
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, WA, WI.
AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaIowaIdahoKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriNorth CarolinaNebraska
Questions about this recall
Is Stryker Mako Vizadisc Hip Procedure Tracking Kit recalled?
Yes. Mako Surgical recalled Stryker Mako Vizadisc Hip Procedure Tracking Kit on 24 Jul 2018. The recall is Class II and its status is Terminated. Recall number Z-2925-2018.
Why was it recalled?
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.
Which lots are affected?
Catalog Number 107130. Lot Numbers 17097K, 17124K, 17129K, 17136K, 17143K, 17103H. **EXPANSION** Lot Numbers 17007K, 17013K, 17024K, 17035K, 17054K, 16354H.
Where was it sold?
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, WA, WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mako Surgical
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Stryker USB Converter, Polaris Spectra Camera recalled by Mako Surgical | Mako Surgical | Device Malfunction | AZ, IL |
| Device | CLASS II | Mako Integrated Cutting System (MICS) Handpiece recalled | Mako Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Mako Hip End Effector, Variable Angle recalled by Mako Surgical | Mako Surgical | Other | 8 states |
| Device | CLASS II | 7 Degree Straight Sagittal Saw attachment recalled by Mako Surgical | Mako Surgical | Other | 13 states |
| Device | CLASS II | 7 Degree Angled Sagittal Saw attachment recalled by Mako Surgical | Mako Surgical | Other | 13 states |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |