Mako Surgical Corporation: Medical Device Recall in 2018 - (Recall #: Z-2925-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Stryker Mako Vizadisc Hip Procedure Tracking Kit

Product Classification:

Class II

Date Initiated: July 24, 2018

Date Posted: September 5, 2018

Recall Number: Z-2925-2018

Event ID: 80621

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.

Status: Terminated

Product Quantity: 19,906 total devices

Code Information:

Catalog Number 107130. Lot Numbers 17097K, 17124K, 17129K, 17136K, 17143K, 17103H. **EXPANSION** Lot Numbers 17007K, 17013K, 17024K, 17035K, 17054K, 16354H.

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.

Voluntary or Mandated:

Voluntary: Firm initiated