Z-0575-2014 Class II Terminated
FDA device recall Z-0575-2014 was initiated by SpineFrontier, Inc. on Nov 20, 2013 and is designated Class II. Reason for recall: Mismarked and unmarked screws The recall status is terminated (terminated Sep 6, 2018).
Recall details
- Product Type
- Devices
- Report Date
- Jan 1, 2014
- Initiation Date
- Nov 20, 2013
- Termination Date
- Sep 6, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
Product description
Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior Cervical Plate in position.
Reason for recall
Mismarked and unmarked screws
Distribution pattern
Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI.
Code information
Lot/Serial Number: IM71 0 16-01: Lots 0000, 000 1
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0575-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026