PlainRecalls
FDA Devices Moderate Class II Terminated

PRO-STIM 10cc INJECTABLE, Part Number 86SR0410

Reported: December 4, 2019 Initiated: November 8, 2016 #Z-0564-2020

Product Description

PRO-STIM 10cc INJECTABLE, Part Number 86SR0410

Reason for Recall

The firm discovered a lack of adequate documentation confirming sterility on certain products.

Details

Units Affected
19 units
Distribution
US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
Location
Arlington, TN

Frequently Asked Questions

What product was recalled?
PRO-STIM 10cc INJECTABLE, Part Number 86SR0410. Recalled by Wright Medical Technology, Inc.. Units affected: 19 units.
Why was this product recalled?
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 4, 2019. Severity: Moderate. Recall number: Z-0564-2020.