FDA Medical Device Recalls (openFDA)
Exactech, Inc.: Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.
- Recall number
- Z-2059-2015
- Recalling firm
- Exactech, Inc.
- Product
- Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.
- Status
- Terminated
- Initiated
- 2009-03-06
- Posted
- 2015-07-10
- Terminated
- 2015-07-14
- Reason
- Incorrect thread form on the screw.
- Root cause
- Device Design
- Action
- Consignees were notified with a Product Recall Notice on 03/06/2009 that all screws must be checked to ensure that any discrepant products to be removed from the field.
- Quantity
- 749 devices
- Distribution
- Distributed in the states of FL, GA, IL, NY, TX, and WA.
- Lot, serial or model codes
- Catalog Number 28202, Lot Number AS05107
- 510(k) numbers
- ["K051216"]
- PMA numbers
- not on file
- Product code
- MNH
- Firm FEI
- 1038671
- Firm city
- Gainesville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28