The Recall Desk
HighFDA (Devices)·Z-2925-2018·Announced 2018-09-05

Stryker Mako Vizadisc Hip Procedure Tracking Kit Recall for Detection Failure

Mako Surgical Corporation is recalling specific lots of the Stryker Mako Vizadisc Hip Procedure Tracking Kit because damaged reflective material may prevent camera detection.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a functional failure of a medical device that could impact surgical procedures, but the source text does not report any injuries, illnesses, or fatalities, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Mako Surgical Corporation is recalling specific lots of the Stryker Mako Vizadisc Hip Procedure Tracking Kit. The recall affects 19,906 total devices distributed in the United States across 32 states, including 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, and WI.

The recall is due to a potential defect where the Vizadisc reflective material may be damaged, causing an inability for the camera to detect the device. The source text notes that specific lots of both the Hip and Knee Procedure Tracking Kits are affected by this issue.

Healthcare providers should check their inventory for the affected catalog number 107130 and the specific lot numbers listed in the recall notice. Affected lots include 17097K, 17124K, 17129K, 17136K, 17143K, 17103H, 17007K, 17013K, 17024K, 17035K, 17054K, and 16354H.

The recalled product

Product
Stryker Mako Vizadisc Hip Procedure Tracking Kit
Manufacturer
Mako Surgical Corporation
Category
Medical Device — Surgical Tracking
Hazard
Affected units
19,906

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

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

Distribution

Distributed in 35 states:

Part of a larger recall action

This product is one of 2 recalled by Mako Surgical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Mako Surgical Corporation

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Same hazard · detection failure

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