SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix SlimLine, SlimLine Hybrid, Corpectomy, ThinLine and An
FDA device recall Z-0292-06 · posted 2005-12-17 · Terminated
Recall details
- Recalling firm
- Abbott Spine
- Reason for recall
- Modification to labeling for surgical implant.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- Approximately 941 SC-AcuFix Core Instruments Surgical Techniques
- Distribution
- Nationwide. Surgical Techniques for the SC-AcuFix Anterior Cervical Plating Systems distributed to Sales Agencies and surgeons throughout the U.S.
- Date initiated
- 2005-11-14
- Date posted
- 2005-12-17
- Date terminated
- 2007-10-02
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM (K024326) | Spinal Concepts, Inc. | 2003-01-23 |
| SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM (K013979) | Spinal Concepts, Inc. | 2002-02-13 |
| SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM (K990005) | Spinal Concepts, Inc. | 1999-02-12 |