FDA-Device2019-12-04Class II

SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104

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
SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0562-2020

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