CLASS II Device recall · Reported 23 Jul 2014 · FDA Enforcement Report

Excella II Standard Pedicle Screw recalled by Innovasis

Innovasis is recalling Excella II Standard Pedicle Screw, distributed nationwide in the US. The recall was initiated on 7 Jul 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesE2S47525 Lot 1301 and E2S47535 Lot 1301

Quantity recalled32

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-2067-2014
FDA event ID: 68781
Recalling firm: Innovasis, Salt Lake City, UT
Classification: Class II
Status: Terminated
Recall initiated: 7 Jul 2014
FDA classified: 16 Jul 2014
Reported: 23 Jul 2014
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Labeling Errors
Device type: Spinal Implants

Timeline

7 Jul 2014	Recall initiated by company
16 Jul 2014	Classified by FDA	+9 days
23 Jul 2014	Published in enforcement report	+7 days

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

Reason for recall

Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.

Product as listed by the FDA

Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.

Where it was distributed

Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.

Nationwide California Kansas Minnesota Oklahoma Texas

Questions about this recall

Why was it recalled?

Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.

Which lots are affected?

E2S47525 Lot 1301 and E2S47535 Lot 1301

Where was it sold?

Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.

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.

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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
28 Feb 2018Device	CLASS II	Excella II Polyaxial Pedicle Screw used as a pedicle screw recalled	Innovasis	Device Malfunction	UT
31 May 2017Device	CLASS II	Opteryx Variable Rescue Screw, Part #CP2214 recalled by Innovasis	Innovasis	Foreign Material	Nationwide

Other Spinal Implants recalls

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Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as: Spinal CDS recalled	Medline Industries	Packaging Defects	Nationwide
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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