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.
What this means for you
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.
See all 2 products in this recall →Related recalls
Same manufacturer · Mako Surgical Corporation
See all →- ModerateStryker USB Converter in Mako Robotic Surgery System May Fail
FDA (Devices) · 2022-09-21
- HighMako MICS Handpiece Recalled for Potential Bone Preparation Discrepancies
FDA (Devices) · 2020-11-25
- HighMako Hip End Effector Recalled for Potential Bone Preparation Discrepancy
FDA (Devices) · 2020-08-12
- ModerateMako Surgical Recalls 2.7 Degree Angled Sagittal Saw Attachments
FDA (Devices) · 2019-06-26
- ModerateMako Surgical Recalls 2.7 Degree Straight Sagittal Saw Attachments
FDA (Devices) · 2019-06-26
Same hazard · functional defect
See all →- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
- HighStryker Ahto Tube Set Recalled for Handpiece Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighAngiodynamics Soft-Vu Angiographic Catheter Guidewire Blockage Risk
FDA (Devices) · 2026-04-29
- SevereGE Healthcare CARESTATION anesthesia systems ventilation malfunction recall
FDA (Devices) · 2025-05-07