Blackstone Medical Inc./ Orthofix Spinal Implants, Hallmark Anterior Cervical Plate System; Plate Bender Part number 62-0070. Non Sterile.
FDA Recall Z-1653-2010 · Posted 2010-05-26
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Recalling FirmBlackstone Medical, Inc.
Recall StatusTerminated
Product CodeKWQ
Date Initiated2010-03-15
Date Terminated2011-09-09
Product Quantity98 units domestically, 14 units internationally.
Reason for Recall
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.
Firm 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 972-529-3024 or Jose Charvet in Product Development at 973-406-2824.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide distribution, including Puerto Rico, and to Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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