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U.S. Department of Health and Human Services

Class 2 Device Recall Rod Connector Assembly

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 Class 2 Recall
Rod Connector Assembly
see related information
Date Posted February 28, 2013
Recall Status1 Terminated on July 01, 2013
Recall Number Z-0896-2013
Recall Event ID 64265
Premarket Notification
510(K) Number
K080407 
Product Classification Appliance, Fixation, Spinal Interlaminal - Product Code KWP
Product Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). Product Usage: The connector assemblies allow for rod components to be connected side-to-side, or end-to-end and eliminate the need of rebuilding the entire system with a longer rod in order to include the new vertebral levels.
Code Information Catalog Numbers: 52-6800 & 52-6700; All Lot Numbers
Recalling Firm/
Manufacturer
Orthofix, Inc
3451 Plano Pkwy
Lewisville, Texas 75056-9453
For Additional Information Contact Diana Easton
214-937-2509
Manufacturer Reason
for Recall
There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connector Assembly (p/n 52-6800) & Axial Rod Connector (p/n 52-6700) may crack during final tightening. Orthofix Inc received six (6) customer complaints related to set screw cracking between November 15, 2010 and December 2012.
FDA Determined
Cause 2
DESIGN: Device Design
Action Orthofix sent an Urgent Medical Device Recall Notification dated February 1, 2013 to all affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to identify and remove the affected products from inventory immediately and follow the actions listed in the enclosed Product Return Instructions. For questions or concerns contact Regulatory Affairs at 214-937-2100.
Quantity in Commerce 565 total (287 PN 52-6800 and 278 PN 52- 6700)
Distribution Worldwidewide Distribution - USA Nationwide including Puerto Rico and the countries of: Australia, Lebanon, Germany, Spain, Sweden and Israel.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KWP and Original Applicant = BLACKSTONE MEDICAL, INC.
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