FDA-Device2019-12-04Class II

CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001

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
42 units
Manufactured in
11576 Memphis Arlington Rd, Arlington, TN, United States
Products
CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0573-2020

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