FDA Device recall Z-2067-2014
Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm
- FDA Device
- Class II
- terminated
- Published 2014-07-23
On 2014-07-23 the FDA classified a Class II recall of Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm by Innovasis, citing innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2067-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-07 |
| Published | 2014-07-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Innovasis |
| Distribution | US |
Product
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.
Reason
Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.
Identifiers
| code_info | E2S47525 Lot 1301 and E2S47535 Lot 1301 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2067-2014%22
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