Recall Z-1028-2022— restor3d Inc.

Name: FDA recall Z-1028-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-30

Class II · Terminated

Class II FDA medical device recall by restor3d Inc., initiated 2022-03-30, terminated 2023-08-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument. Reason: During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots..

Recalling firm: restor3d Inc.
Classification: Class II
Status: Terminated
Initiated: 2022-03-30
Terminated: 2023-08-28
Firm location: Durham, NC, United States

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.