Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Blackstone Medical Hallmark

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Blackstone Medical Hallmark see related information
Date Initiated by Firm March 15, 2010
Date Posted May 26, 2010
Recall Status1 Terminated 3 on September 09, 2011
Recall Number Z-1653-2010
Recall Event ID 55002
510(K)Number K050892  
Product Classification spinal implant surgical instrument - Product Code KWQ
Product Blackstone 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.
Recalling Firm/
Manufacturer		 Blackstone Medical, Inc.
1211 Hamburg Tpke
Suite 300
Wayne NJ 07470
For Additional Information Contact Darla 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
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.
Quantity in Commerce 98 units domestically, 14 units internationally.
Distribution Nationwide distribution, including Puerto Rico, and to Australia.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = KWQ and Original Applicant = BLACKSTONE MEDICAL, INC.
-
-