Z-2924-2018 Class II Terminated
FDA device recall Z-2924-2018 was initiated by Mako Surgical Corporation on July 24, 2018 and is designated Class II. 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 detect… The recall status is terminated (terminated October 11, 2022). Affected quantity: 19,906 total devices.
Recall Details
- Product Type
- Devices
- Report Date
- September 5, 2018
- Initiation Date
- July 24, 2018
- Termination Date
- October 11, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,906 total devices
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.
Distribution Pattern
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.
Code Information
Catalog Number 107120. Lot Numbers 17097K, 17124K, 17129K, 17136K, 17143K, 17103H. **EXPANSION** Lot Numbers 17007K, 17013K, 17024K, 17035K, 17054K, 16354H.