restor3d Inc. recalls Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instru…
- Recall date
- March 30, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1028-2022
- FDA classification
- Class II
- Brand / firm
- restor3d Inc.
- Sold / distributed
- US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.
Why it was recalled
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument
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