Device product
Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.
Z-2059-2015
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 71528
- Status
- Terminated
- Classification
- Class II
- Quantity
- 749 devices
- Official record key
device-enforcement:Z-2059-2015
Official wording
Reason: Incorrect thread form on the screw.
Code information: Catalog Number 28202, Lot Number AS05107
Distribution pattern: Distributed in the states of FL, GA, IL, NY, TX, and WA.
Derived failure modes
-
Unknown
Incorrect thread form on the screw.