Z-2059-2015 Class II Terminated
FDA device recall Z-2059-2015 was initiated by Exactech, Inc. on Mar 6, 2009 and is designated Class II. Reason for recall: Incorrect thread form on the screw. The recall status is terminated (terminated Jul 14, 2015). Affected quantity: 749 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 22, 2015
- Initiation Date
- Mar 6, 2009
- Termination Date
- Jul 14, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 749 devices
Product Description
Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.
Reason for Recall
Incorrect thread form on the screw.
Distribution Pattern
Distributed in the states of FL, GA, IL, NY, TX, and WA.
Code Information
Catalog Number 28202, Lot Number AS05107
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2059-2015
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026