CLASS II Device recall · Reported 28 Feb 2018 · FDA Enforcement Report

Excella II Polyaxial Pedicle Screw used as a pedicle screw recalled

Innovasis is recalling Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature. The recall was initiated on 8 Jan 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog/Part No.: E2S8530, E2S8535, E2S8540, E2S8545, E2S8550, E2S8555, E2S8560 with Lot Number: 1101 and Catalog/Part No.: E28540, E28545 with Lot Number: 1201. Each of these parts is engraved with part number and lot number.

Quantity recalled1,010 parts

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-0644-2018
FDA event ID: 78946
Recalling firm: Innovasis, Salt Lake City, UT
Classification: Class II
Status: Terminated
Recall initiated: 8 Jan 2018
FDA classified: 20 Feb 2018
Reported: 28 Feb 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Spinal Implants

Timeline

8 Jan 2018	Recall initiated by company
20 Feb 2018	Classified by FDA	+43 days
28 Feb 2018	Published in enforcement report	+8 days

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

Reason for recall

Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine:

Where it was distributed

United States

Questions about this recall

Why was it recalled?

Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.

Which lots are affected?

Catalog/Part No.: E2S8530, E2S8535, E2S8540, E2S8545, E2S8550, E2S8555, E2S8560 with Lot Number: 1101 and Catalog/Part No.: E28540, E28545 with Lot Number: 1201. Each of these parts is engraved with part number and lot number.

Where was it sold?

United States

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 26 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 Innovasis

All 7

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Device	CLASS II	Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle recalled	Innovasis	Other	Nationwide
25 Sep 2024Device	CLASS II	TxHA PEEK IBF/TxTiHA IBF System recalled by Innovasis	Innovasis	Other	Nationwide
27 May 2020Device	CLASS II	Oryx Cervical Screw Caddy recalled by Innovasis	Innovasis	Device Malfunction	Nationwide
31 May 2017Device	CLASS II	Opteryx Variable Rescue Screw, Part #CP2214 recalled by Innovasis	Innovasis	Foreign Material	Nationwide
27 Jan 2016Device	CLASS II	Excella II Rod recalled by Innovasis	Innovasis	Packaging Defects	4 states

Other Spinal Implants recalls

All 1,159

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Extended Polyaxial Head, Attached Gimbal recalled	Seaspine Orthopedics	Other	Nationwide
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Anterior Spine Pack recalled	Medline Industries	Other	Nationwide
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