FDA Recall
Terminated
PRO-STIM 10cc INJECTABLE, Part Number 86SR0410
Recall: Z-0564-2020
·
Initiated November 8, 2016
Recall
- Recall Number
- Z-0564-2020
- Event Number
- 84180
- Firm
- Wright Medical Technology, Inc.
- FEI Number
- 1043534
- Product Code
- MBP
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- November 8, 2016
- Terminated
- November 3, 2020
- Address
- 11576 Memphis Arlington Rd, Arlington, TN, 38002-9497
Description
PRO-STIM 10cc INJECTABLE, Part Number 86SR0410
Reason
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Action
The firm initiated the recall on 11/08/2016 by letter and email to the user level. The firm requested the return of the units.
Distribution
US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
Quantity
19 units