Recall Z-0363-2008 ยท MNI Orthosis, Spinal Pedicle Fixation
Blackstone Medical, Inc.
Ascent POCTS (Posterior Occipital Cervical Thoracic System) Part Numbers: 65-33 XX Series (65-3310,-3312, -3314, -3318, -3320-, -3322, -3324, -3326, -3328, and -3330), Multi-Axial Screw, 4.0mm x 26mm;Implant grade Titanium Alloy; Blacksone Medical Inc., 90 Brookdale Drive, Springfield, MA 01104.
| Date | Dec 11, 2007 (initiated May 15, 2007) |
| Status | Terminated |
| Reason | Manufacturing Defect: The saddle of the screw's body relative to the keyway exceeds the tolerance outlined in the device specifications. The extent to which the tolerance is exceeded varies from part to part, in the extreme the tolerance is exceeded by (+) 50%. As a consequence, there is a potential for set-screw cross-threading during implantation. Cross-threading could in turn lead to a comprom |
| Root cause | Nonconforming Material/Component |
| Action | Blackstone Medical, Inc., field representatives were notified via phone, e-mail or fax on 4/30/07. Attention: Notification of Product Removal Letters were sent on May 15, 2007, to distributors and implanting surgeons requesting return of non-implanted stock. |
| Quantity | 319 screws ( 212 domestic, 107 international) |
| Distribution | Worldwide: USA and countries of China, Cyprus, Turkey and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.