Evans Opening Wedge Plate 10mm recall: Sterility Concern
EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010
Why was Evans Opening Wedge Plate 10mm recalled?
The firm discovered a lack of adequate documentation confirming sterility on certain products.
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?
Lot Number 1556150
- Product
- EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010
- Recalling firm
- Wright Medical Technology, Inc.
- Quantity
- 30 units
- Distribution
- US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
- Recall date
- December 4, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)