Recall Z-1653-2010 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Blackstone Medical, Inc.
Blackstone Medical Inc./ Orthofix Spinal Implants, Hallmark Anterior Cervical Plate System; Plate Bender Part number 62-0070. Non Sterile.
| Date | May 26, 2010 (initiated Mar 15, 2010) |
| Status | Terminated |
| Reason | The Hallmark Anterior Cervical Plate Bender may have a non conformity causing difficulty accepting 3-4 level plates or to not accept 3-4 level plates that are intended to be additionally contoured. |
| Root cause | Nonconforming Material/Component |
| Action | Orthofix send letters of notification of planned product removal to distributors who keep the instrumentation set on 3/29/2010 by Fed Ex. Letters of planned product removal explain the reason for the planned removal and the specific product involved. Replacement product will not be available until July 2010, however, the firm elected to notify customers of the potential problem and the date that formal notification and replacement Plate Benders will be available. Letters state that if there is any problem with the Plate Benders, questions can be directed to David Thompson in Marketing at 972 |
| Quantity | 98 units domestically, 14 units internationally. |
| Distribution | Nationwide distribution, including Puerto Rico, and to Australia. |
| 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 |