Device product
Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue Anterior Cervical Plate in position.
Z-0573-2014
Product summary
- Event
- Event 66914
- Status
- Terminated
- Classification
- Class II
- Quantity
- 993
- Official record key
device-enforcement:Z-0573-2014
Official wording
Reason: Mismarked and unmarked screws
Code information: Lot/Serial Number: IM71058-0l: Lot 0000; IM71058-02: Lot 0000; IM71058-03 : Lot 0000
Distribution pattern: Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI.
Derived failure modes
-
Unknown
Mismarked and unmarked screws