FDA-Device2019-12-04Class II

PRO-STIM 10cc INJECTABLE, Part Number 86SR0410

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
19 units
Manufactured in
11576 Memphis Arlington Rd, Arlington, TN, United States
Products
PRO-STIM 10cc INJECTABLE, Part Number 86SR0410

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0564-2020

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