FDA recall Z-1028-2022

restor3d Inc. · Class II · device

Product

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

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2022-03-30
Report date
2022-05-11
Termination date
2023-08-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Durham, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1028-2022