FDA Medical Device Recalls (openFDA)
Abbott Spine: TraXis Fixed Rasp in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; for use with TraXis vertebral body replacement system
- Recall number
- Z-0355-2007
- Recalling firm
- Abbott Spine
- Product
- TraXis Fixed Rasp in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; for use with TraXis vertebral body replacement system
- Status
- Terminated
- Initiated
- 2006-11-07
- Posted
- 2007-01-17
- Terminated
- 2007-10-11
- Reason
- Tip of devices may dislodge while in use during surgery.
- Root cause
- Other
- Action
- All consignees that have the affected TraXis Fixed Rasps and TraXis Fixed Trials will be contacted via a documented phone script 11/07/2006. Affected inventory will be exchanged for re-worked instruments.
- Quantity
- 66 units.
- Distribution
- Worldwide, including USA, Spain, Mexico, United Kingdom, Germany, and Cyprus
- Lot, serial or model codes
- Part #2664-1-07 (7mm), 2664-1-09 (9mm), 2664-1-11 (11mm), 2664-1-13 (13mm), 2664-1-15 (15mm).
- 510(k) numbers
- not on file
- 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