FDA Enforcement
Class II
Terminated
PRO-STIM 10cc INJECTABLE, Part Number 86SR0410
Recall: Z-0564-2020
·
Reported December 4, 2019
Enforcement
- Recall Number
- Z-0564-2020
- Event ID
- 84180
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Wright Medical Technology, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 4, 2019
- Initiation Date
- November 8, 2016
- Classification Date
- November 25, 2019
- Termination Date
- November 3, 2020
- Address
- 11576 Memphis Arlington Rd, Arlington, TN, 38002-9497, United States
Description
PRO-STIM 10cc INJECTABLE, Part Number 86SR0410
Reason
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Code Info
Lot Number 1564697
Distribution
US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
Quantity
19 units