Medical device recalls Moderate risk

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

Get recall alerts

Free email alert whenever restor3d Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: restor3d Inc.