Reported Sep 5, 2018 · Terminated
Stryker Mako Vizadisc Knee Procedure Tracking Kit
Mako Surgical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mako Surgical Corporation · 2555 Davie Rd Ste 110 · Davie, FL · 33317-7424
Is this the product you have?
- Stryker Mako Vizadisc Knee Procedure Tracking Kit
- Lot codes and dates
Catalog Number 107120. Lot Numbers 17097K17124K17129K17136K17143K17103H. **EXPANSION** Lot Numbers 17007K17013K17024K17035K17054K16354H
- Amount recalled
- 19,906 total devices
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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