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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm April 21, 2010
Date Posted May 19, 2010
Recall Status1 Terminated 3 on August 10, 2010
Recall Number Z-1613-2010
Recall Event ID 55508
Product Classification Tap, bone - Product Code HWX
Product 6.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069.

Intended to created a screw thread in a hole drilled into bone to facilitate placement of a bone screw.
Code Information Part Number 52-1026; Lot numbers16380-xxxx and 17162-xxxx
Recalling Firm/
Manufacturer		 Blackstone Medical, Inc.
1211 Hamburg Tpke
Suite 300
Wayne NJ 07470
For Additional Information Contact Randal Vader
973-529-3121
Manufacturer Reason
for Recall		 Certain lots of the non-cannulated Modular Bone Taps used with the Firebird Spinal Fixation Systems may contain a manufacturing non conformance resulting in the taps creating a single lead screw thread rather than the required dual lead screw thread.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Orthofix issued an "Urgent Product Recall" notification dated April 21, 2010 by USPS certified mail to hospitals and distributors. Consignees were asked to return all affected product to the firm. For additional information, contact the Orthofix Regulatory Affairs Department at 1-973-406-2847.
Quantity in Commerce 92
Distribution Nationwide and to one location each in Australia and Spain.
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.
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