CLASS II Device recall · Reported 22 Jul 2015 · FDA Enforcement Report

Altiva / Exactech Spine, Large Set Screw recalled

Exactech is recalling Altiva / Exactech Spine, Large Set Screw, distributed in Florida, Georgia, Illinois, New York, Texas, Washington. The recall was initiated on 6 Mar 2009 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number 28202, Lot Number AS05107

Quantity recalled749 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2059-2015
FDA event ID: 71528
Recalling firm: Exactech, Gainesville, FL
Classification: Class II
Status: Terminated
Recall initiated: 6 Mar 2009
FDA classified: 10 Jul 2015
Reported: 22 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

6 Mar 2009	Recall initiated by company
10 Jul 2015	Classified by FDA	+2317 days
22 Jul 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Incorrect thread form on the screw.

Product as listed by the FDA

Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.

Where it was distributed

Distributed in the states of FL, GA, IL, NY, TX, and WA.

Florida Georgia Illinois New York Texas Washington

Questions about this recall

Is Altiva / Exactech Spine, Large Set Screw recalled?

Yes. Exactech recalled Altiva / Exactech Spine, Large Set Screw on 6 Mar 2009. The recall is Class II and its status is Terminated. Recall number Z-2059-2015.

Why was it recalled?

Incorrect thread form on the screw.

Which lots are affected?

Catalog Number 28202, Lot Number AS05107

Where was it sold?

Distributed in the states of FL, GA, IL, NY, TX, and WA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Exactech

All 197

Reported	Class	Recall	Company	Reason	Where
18 Mar 2026Device	CLASS II	Equinoxe Core Instrument Kit recalled by Exactech	Exactech	Other	19 states
18 Mar 2026Device	CLASS II	Equinoxe Ergo Ergo Modular Impactor Handle recalled by Exactech	Exactech	Other	19 states
26 Nov 2025Device	CLASS II	Equinoxe Ergo Adjustable Angle rTSA Reamer recalled by Exactech	Exactech	Device Malfunction	SC
26 Nov 2025Device	CLASS II	Equinoxe Ergo Ergo Augments Pilot Tip Converter recalled by Exactech	Exactech	Device Malfunction	SC
26 Nov 2025Device	CLASS II	Equinoxe Ergo Adjustable Angle rTSA Reamer recalled by Exactech	Exactech	Device Malfunction	SC

Other Spinal Implants recalls

All 1,157

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	AVID Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: ENT recalled	AVID Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: A-P PACK recalled	AVID Medical	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide