FDA Medical Device Recalls (openFDA)
Innovasis, Inc: 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.
- Recall number
- Z-2067-2014
- Recalling firm
- Innovasis, Inc
- 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.
- Status
- Terminated
- Initiated
- 2014-07-07
- Posted
- 2014-07-16
- Terminated
- 2014-08-11
- Reason
- Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.
- Root cause
- Process control
- Action
- Distributors were notified by e-mail on 7/7/14, with attached copies of the written letter and forms to be printed, signed and returned to Innovasis. Distributors have been instructed to return all inventory in stock.
- Quantity
- 32
- Distribution
- Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.
- Lot, serial or model codes
- E2S47525 Lot 1301 and E2S47535 Lot 1301
- 510(k) numbers
- ["K102248","K140238"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 3004719693
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28