Evans Wedge Disposable Trials recall
Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
Why was Evans Wedge Disposable Trials recalled?
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model: 6101-20181018; Lot: 2022010031; UDI: 00840097501574
- Product
- Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
- Recalling firm
- restor3d Inc.
- Quantity
- 4 units
- Distribution
- US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.
- Recall date
- May 11, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)