Recall Z-0478-2008 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Blackstone Medical, Inc.
Hallmark Anterior Cervical Plate System: Primary Bone Screw, Semi Constrained, REF # 62-3140,14mm; Blackstone Medical, 90 Brookdale Drive, Springfield, MA 01104 (The Hallmark Anterior Cervical Plate Systems consists of an assortment of implantable titanium alloy plates and bone screws that are provided non-sterile)
| Date | Jan 26, 2008 (initiated May 8, 2006) |
| Status | Terminated |
| Reason | Incomplete Design Validation: the laser marking on the head of the screw lacked complete process qualification |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 1,991 semi-constrained primary and rescue screws. |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050892 | HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM Blackstone Medical, Inc., May 11, 2005 |