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restor3d Inc. recalls Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
Recalled May 11, 2022 · FDA recall Z-1027-2022 · restor3d
Hazard
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots. · FDA Class II
Units
4 units
Sold at
US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.
Description
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
Product
Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
Manufacturer(s)
restor3d Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →