FDAMarch 30, 2022device
Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
What to do
FDA enforcement status: Terminated
Brands named
restor3d
UPCs
61012018101800840097501574
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDANon-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument2022-03-30
- FDAEvans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument2022-03-30
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →