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U.S. Department of Health and Human Services

Class 2 Device Recall Blackstone Medical Hallmark

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 Class 2 Device Recall Blackstone Medical Hallmarksee related information
Date Initiated by FirmMarch 15, 2010
Date PostedMay 26, 2010
Recall Status1 Terminated 3 on September 09, 2011
Recall NumberZ-1653-2010
Recall Event ID 55002
510(K)NumberK050892 
Product Classification spinal implant surgical instrument - Product Code KWQ
ProductBlackstone Medical Inc./ Orthofix Spinal Implants, Hallmark Anterior Cervical Plate System; Plate Bender Part number 62-0070. Non Sterile.
Code Information Part number 62-0070, all lots.
FEI Number 3001238051
Recalling Firm/
Manufacturer		 Blackstone Medical, Inc.
1211 Hamburg Tpke
Suite 300
Wayne NJ 07470
For Additional Information ContactDarla Chew
469-742-8824
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOrthofix 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.
Quantity in Commerce98 units domestically, 14 units internationally.
DistributionNationwide distribution, including Puerto Rico, and to Australia.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KWQ
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