FDA Medical Device Recalls (openFDA)
Abbott Spine: TraXis Vue Spinal Implant System, Part #2601-090921
- Recall number
- Z-0502-06
- Recalling firm
- Abbott Spine
- Product
- TraXis Vue Spinal Implant System, Part #2601-090921
- Status
- Terminated
- Initiated
- 2005-11-02
- Posted
- 2006-02-07
- Terminated
- 2007-09-25
- Reason
- Implants were manufactured without radiographic markers.
- Root cause
- Other
- Action
- Firm initiated phone contact of all Sales Representatives who received lot and surgeons who have implanted lot on 11/02/05. Recall Letters to be sent to surgeons who have implanted affected lot.
- Quantity
- 41 units
- Distribution
- Nationwide. Implants distributed to Sales Representatives in AZ, CA, FL, GA, KY, IL, MA, NY, OK, PA, TX, UT, VA and WI.
- Lot, serial or model codes
- Lot #2010292
- 510(k) numbers
- ["K031855"]
- PMA numbers
- not on file
- Product code
- MQP
- Firm FEI
- 3000718496
- Firm city
- Austin
- Firm state
- TX
- 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