Recall Z-1144-2010 ยท MNI Orthosis, Spinal Pedicle Fixation
Blackstone Medical, Inc.
Ascent Posterior Occipital Cervical Thoracic System, Single Looped Cable with Two Crimps, One Each. Distributed by Blackstone Medical, Springfield, MA. Intended to promote fusion of the cervical spine and occipitothoracic junction.
| Date | Mar 16, 2010 (initiated Feb 2, 2010) |
| Status | Terminated |
| Reason | The Ascent Posterior Occipital Cervical Thoracic System Single Looped Cable with two crimps may be made of stainless steel instead of Titanium. |
| Root cause | Labeling mix-ups |
| Action | Orthofix Spinal Implants contacted customers by phone beginning December 22, 2009 and issued a Notification of Product Removal dated February 2, 2010. Consignees were instructed to Identify, Remove and Return all affected product to the firm. For further information, contact Orthofix Spinal Implants, Regulatory Affairs Department at 1-973-406-2812. |
| Quantity | 25 |
| Distribution | Worldwide Distribution -- United States (Texas and California), Australia, Colombia and Greece. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030197 | BLACKSTONE POSTERIOR CERVICAL SYSTEM Blackstone Medical, Inc., Jun 12, 2003 |