FDA-Device2022-05-11Class II
Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
restor3d Inc.
Hazard
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
Sold states
US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.
Affected count
4 units
Manufactured in
311 W Corporation St, N/A, Durham, NC, United States
Products
Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1027-2022Don't want to check this manually?
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