SC-AcuFix Thinline Low-Profile Anterior Cervical Plate System manufactured by Spinal Concepts, Inc., An Abbott Laborator
FDA device recall Z-0880-05 · posted 2005-06-11 · Terminated
Recall details
- Recalling firm
- Spinal Concepts, Inc
- Reason for recall
- Complaints were recieved where swivels came out of plate and where the screw went through the plate.
- Action taken
- The firm initiated the recall via telephone communication from sales representatives around August 2002.
- Root cause
- Other
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- 10 systems
- Distribution
- Systems were distributed to hospitals in CA, IL, IN, NC, MS, PA, NY and VA
- Date initiated
- 2002-07-01
- Date posted
- 2005-06-11
- Date terminated
- 2005-12-20
- 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 |
|---|---|---|
| SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM (K013979) | Spinal Concepts, Inc. | 2002-02-13 |