Stryker Mako Vizadisc Knee Procedure Tracking Kit
Reported: September 5, 2018 Initiated: July 24, 2018 #Z-2924-2018
Product Description
Stryker Mako Vizadisc Knee 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.
Details
- Recalling Firm
- Mako Surgical Corporation
- Units Affected
- 19,906 total devices
- 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, WA, WI.
- Location
- Davie, FL
Frequently Asked Questions
What product was recalled? ▼
Stryker Mako Vizadisc Knee Procedure Tracking Kit. Recalled by Mako Surgical Corporation. Units affected: 19,906 total devices.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on September 5, 2018. Severity: Moderate. Recall number: Z-2924-2018.
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