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U.S. Department of Health and Human Services

Class 2 Device Recall Hallmark

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  Class 2 Device Recall Hallmark see related information
Date Initiated by Firm May 08, 2006
Date Posted January 26, 2008
Recall Status1 Terminated 3 on November 06, 2008
Recall Number Z-0478-2008
Recall Event ID 45513
510(K)Number K050892  
Product Classification Cervical Plate System - Product Code KWQ
Product Hallmark Anterior Cervical Plate System: Primary Bone Screw, Semi Constrained, REF # 62-3140,14mm; Blackstone Medical, 90 Brookdale Drive, Springfield, MA 01104 (The Hallmark Anterior Cervical Plate Systems consists of an assortment of implantable titanium alloy plates and bone screws that are provided non-sterile)
Code Information All Lots (Primary semi-contained rescue Screws: P/N's 62-3100 through 62-3180 and rescue simi-constrained bone screws P/N's 62-4100- 62-4180)
Recalling Firm/
Manufacturer		 Blackstone Medical, Inc.
1211 Hamburg Tpke
Suite 300
Wayne NJ 07470
For Additional Information Contact
973-406-2869
Manufacturer Reason
for Recall		 Incomplete Design Validation: the laser marking on the head of the screw lacked complete process qualification
FDA Determined
Cause 2		 Device Design
Action On May 8, 2006, a communication to the field was sent via phone, e-mail and fax. Instruction was made to retrieve and return all product in the field.
Quantity in Commerce 1,991 semi-constrained primary and rescue screws.
Distribution Nationwide
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.
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