CLASS II Device recall · Reported 27 Jan 2016 · FDA Enforcement Report
Excella II Rod recalled by Innovasis
Innovasis is recalling Excella II Rod, distributed in California, Kansas, Ohio, Texas. The recall was initiated on 7 Dec 2015 and the FDA has classified it as Class II.
Check your package
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-0662-2016
- FDA event ID
- 72878
- Recalling firm
- Innovasis, Salt Lake City, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Dec 2015
- FDA classified
- 19 Jan 2016
- Reported
- 27 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Spinal Implants
Timeline
| 7 Dec 2015 | Recall initiated by company | |
| 19 Jan 2016 | Classified by FDA | +43 days |
| 27 Jan 2016 | 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
Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set. Intended for use in the non-cervical area of the spine.
Where it was distributed
Distributed in US -- CA; KS; OH; & TX.
Questions about this recall
Why was it recalled?
Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
Which lots are affected?
Catalog No.: SR55110 Lot 1502 and SR55100 Lot 1502
Where was it sold?
Distributed in US -- CA; KS; OH; & TX.
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 |
|---|---|---|---|---|---|
| Device | CLASS II | Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle recalled | Innovasis | Other | Nationwide |
| Device | CLASS II | TxHA PEEK IBF/TxTiHA IBF System recalled by Innovasis | Innovasis | Other | Nationwide |
| Device | CLASS II | Oryx Cervical Screw Caddy recalled by Innovasis | Innovasis | Device Malfunction | Nationwide |
| Device | CLASS II | Excella II Polyaxial Pedicle Screw used as a pedicle screw recalled | Innovasis | Device Malfunction | UT |
| Device | CLASS II | Opteryx Variable Rescue Screw, Part #CP2214 recalled by Innovasis | Innovasis | Foreign Material | Nationwide |
Other Spinal Implants recalls
All 1,159| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Extended Polyaxial Head, Attached Gimbal recalled | Seaspine Orthopedics | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Anterior Spine Pack recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |