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
E-Mail
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