FDA Medical Device Recalls (openFDA)
Innovasis, Inc: 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.
- Recall number
- Z-0662-2016
- Recalling firm
- Innovasis, Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2015-12-07
- Posted
- 2016-01-19
- Terminated
- 2016-04-07
- Reason
- Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
- Root cause
- Labeling mix-ups
- Action
- Innovasis sent a Voluntary Product Recall letter, dated December 7, 2015 to customers regarding two lots of Excella II titanium rods which were packaged using each other's labels. Customers were asked to check their inventory and either remove the rod from the mislabeled package and request additional rods, or return the unopened packages immediately. The firm will replace all returned inventory upon receipt.
- Quantity
- 17 units Labeled SR55100 Lot 1502 with SR55110 rods in package
- Distribution
- Distributed in US -- CA; KS; OH; & TX.
- Lot, serial or model codes
- Catalog No.: SR55110 Lot 1502 and SR55100 Lot 1502
- 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