FDA-Device2019-12-04Class II

VALOR SCREW 5.0MM X 45MM LEN, Part Number 4151150045

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
54 units
Manufactured in
11576 Memphis Arlington Rd, Arlington, TN, United States
Products
VALOR SCREW 5.0MM X 45MM LEN, Part Number 4151150045

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0566-2020

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