Z-2059-2015Class II

Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide...

Name: Z-2059-2015 Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide...
Creator: Exactech, Inc.
Published: 2009-03-06
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2009-03-06 / Terminated / root cause: design

FDA source

Exactech, Inc. began a recall of Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments on 2009-03-06. FDA classified it as Class II and gives the reason as "Incorrect thread form on the screw". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2059-2015
Classification: Class II
Status: Terminated
Initiated: 2009-03-06
Posted: 2015-07-10
Terminated: 2015-07-14
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.
Product code: MNH Orthosis, Spondylolisthesis Spinal Fixation
Reason for recall: Incorrect thread form on the screw.
Root cause tag: design
FDA 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 in commerce: 749 devices
Distribution: Distributed in the states of FL, GA, IL, NY, TX, and WA.
Product codes and lots: Catalog Number 28202, Lot Number AS05107

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2059-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2059-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-10

Product code MNH

K051216Class IIHydralok SystemAltiva Corp. / cleared 2005-07-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)