restor3d Inc.: Medical Device Recall in 2022 - (Recall #: Z-1028-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 30, 2022

Date Posted: May 11, 2022

Recall Number: Z-1028-2022

Event ID: 89983

Reason for Recall:

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

Status: Terminated

Product Quantity: 9 units

Code Information:

Model: 6101-22200818; Lot: 2022010035; UDI: 00840097501598

Distribution Pattern:

US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.

Voluntary or Mandated:

Voluntary: Firm initiated