Hallmark Anterior Cervical Plate System: Primary Bone Screw, Semi Constrained, REF # 62-3140,14mm; Blackstone Medical, 9
FDA device recall Z-0478-2008 · posted 2008-01-26 · Terminated
Recall details
- Recalling firm
- Blackstone Medical, Inc.
- Reason for recall
- Incomplete Design Validation: the laser marking on the head of the screw lacked complete process qualification
- Action taken
- On May 8, 2006, a communication to the field was sent via phone, e-mail and fax. Instruction was made to retrieve and return all product in the field.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- 1,991 semi-constrained primary and rescue screws.
- Distribution
- Nationwide
- Date initiated
- 2006-05-08
- Date posted
- 2008-01-26
- Date terminated
- 2008-11-06
- Location
- Wayne, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM (K050892) | Blackstone Medical, Inc. | 2005-05-11 |