FDA-Device2019-12-04Class II
INBONE STEM, TIBIAL, TOP, Part Number 200011901
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
65 units
Manufactured in
11576 Memphis Arlington Rd, Arlington, TN, United States
Products
INBONE STEM, TIBIAL, TOP, Part Number 200011901
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0565-2020Don't want to check this manually?
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