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.
FDA Recall Z-0363-2008 · Posted 2007-12-11
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Recalling FirmBlackstone Medical, Inc.
Recall StatusTerminated
Product CodeMNI
Date Initiated2007-05-15
Date Terminated2008-06-06
Product Quantity319 screws ( 212 domestic, 107 international)
Reason for Recall
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
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide: USA and countries of China, Cyprus, Turkey and Switzerland.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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