FDA Medical Device Recalls (openFDA)
Abbott Spine: SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix SlimLine and SlimLine Hybrid Anterior Cervical Plating Systems.
- Recall number
- Z-0293-06
- Recalling firm
- Abbott Spine
- Product
- SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix SlimLine and SlimLine Hybrid Anterior Cervical Plating Systems.
- Status
- Terminated
- Initiated
- 2005-11-14
- Posted
- 2005-12-17
- Terminated
- 2007-10-02
- Reason
- Modification to labeling for surgical implant.
- Root cause
- Other
- Action
- Firm contact of Sales Agencies by phone began on 11/11/05 to inform of changes to Surgical Techniques. Letter to surgeons using SC-AcuFix Systems as of 06/01/05 sent 11/14/05.
- Quantity
- Approximately 2910 SC-AcuFix SlimLine Surgical Techniques
- Distribution
- Nationwide. Surgical Techniques for the SC-AcuFix Anterior Cervical Plating Systems distributed to Sales Agencies and surgeons throughout the U.S.
- Lot, serial or model codes
- SC-AcuFix SlimLine Surgical Techniques: Doc #499-0005-MKC, rev D.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KWQ
- 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