medical Class II Updated 2022-05-11

restor3d Inc. recalls Evans Wedge Disposable Trials, Large Footprint, 8mm Thicknes

Recalled Product

Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument

Hazard / Issue

During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model: 6101-22200818; Lot: 2022010035; UDI: 00840097501598
View official government recall

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