FDAFDA · Food and drugs·Recall number Z-0575-2014
Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior Cervical Plate in position.
Published January 1, 2014 · Recall initiated: November 20, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Mismarked and unmarked screws
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SpineFrontier, Inc.
- Distributor
- Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI.
- Lot
- Lot/Serial Number: IM71 0 16-01: Lots 0000, 000 1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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