FDA Enforcement
Class II
Terminated
WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Medium, OD: 10mm, L: 200mm, REF415101020
Recall: Z-1375-2018
·
Reported April 25, 2018
Enforcement
- Recall Number
- Z-1375-2018
- Event ID
- 79581
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Wright Medical Technology, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- April 25, 2018
- Initiation Date
- March 14, 2018
- Classification Date
- April 13, 2018
- Termination Date
- October 5, 2020
- Address
- 11576 Memphis Arlington Rd, Arlington, TN, 38002-9497, United States
Description
WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Medium, OD: 10mm, L: 200mm, REF415101020
Reason
Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw.
Code Info
Lot 1608296
Distribution
US and Argentina, Belgium, Brazil, Chile, Colombia, Germany, Italy, Mexico, Peru, Thailand, and United Kingdom
Quantity
47 units