Device product
Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
Z-0576-2014
Product summary
- Event
- Event 66914
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-0576-2014
Official wording
Reason: Mismarked and unmarked screws
Code information: Lot/Serial Number: IM71013-01: 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