FDA-Device2022-04-13Class II
Total Knee Pack - Surgical Kit
Stradis Medical, LLC dba Stradis Healthcare
Hazard
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Sold states
US Nationwide distribution in the states of IN, TX, and PA.
Affected count
76 units
Manufactured in
3025 Northwoods Pkwy, Peachtree Corners, GA, United States
Products
Total Knee Pack - Surgical Kit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0864-2022Don't want to check this manually?
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