Stryker Mako Vizadisc Knee Procedure Tracking Kit Recalled for Detection Issues
Mako Surgical Corporation is recalling specific lots of the Stryker Mako Vizadisc Knee Procedure Tracking Kit because the reflective material may be damaged, preventing camera detection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional defect (inability to be detected by camera) without reporting any injuries, illnesses, or fatalities, fitting the criteria for a moderate severity recall.
Plain-English summary
Mako Surgical Corporation is recalling specific lots of the Stryker Mako Vizadisc Knee Procedure Tracking Kit. The recall involves 19,906 total devices distributed in the United States across 33 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 was initiated because 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. This damage can cause an inability for the material to be detected by the camera.
The affected products are identified by Catalog Number 107120. The specific lot numbers involved are 17097K, 17124K, 17129K, 17136K, 17143K, 17103H, 17007K, 17013K, 17024K, 17035K, 17054K, and 16354H. Healthcare providers and facilities should check their inventory for these specific catalog and lot numbers and stop using the affected devices.
The recalled product
- Product
- Stryker Mako Vizadisc Knee Procedure Tracking Kit
- Manufacturer
- Mako Surgical Corporation
- 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 107120. Lot Numbers 17097K
- 17124K
- 17129K
- 17136K
- 17143K
- 17103H. **EXPANSION** Lot Numbers 17007K
- 17013K
- 17024K
- 17035K
- 17054K
- 16354H.
Distribution
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.
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