Reported May 11, 2022 · Terminated
Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical…
restor3d Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: restor3d Inc. · 311 W Corporation St · Durham, NC · 27701-2409
Is this the product you have?
- Evans Wedge Disposable Trials, Large Footprint, 8mm
- Thickness (Model6101-22200818). Orthopedic manual surgical instrument
- Lot codes and dates
- Model6101-22200818
- Lot2022010035
- UDI00840097501598
- Amount recalled
- 9 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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