FDA-Device2019-12-04Class II
EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010
Wright Medical Technology, Inc.
Hazard
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Sold states
US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
Affected count
30 units
Manufactured in
11576 Memphis Arlington Rd, Arlington, TN, United States
Products
EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0569-2020Don't want to check this manually?
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