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U.S. Department of Health and Human Services

Class 2 Device Recall Tipped Tapered Solid Driver (Screwdriver)

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 Class 2 Recall
Tipped Tapered Solid Driver (Screwdriver)
see related information
Date Posted August 13, 2013
Recall Status1 Terminated on January 10, 2014
Recall Number Z-1957-2013
Recall Event ID 64994
Premarket Notification
510(K) Numbers
K093776  K121060 
Product Classification Screwdriver - Product Code HXX
Product Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral.
Code Information Lot Number: 011836-0001, 011981-001
Recalling Firm/
Manufacturer
SpineFrontier, Inc.
500 Cummings Ctr Ste 3500
Beverly, Massachusetts 01915-6516
Manufacturer Reason
for Recall
The nipple of the tipped driver broke off when surgeons were attempting to insert the screw.
FDA Determined
Cause 2
DESIGN: Device Design
Action On May 9, 2012 an email was sent to consignees requesting that the product be returned for servicing and that a replacement part would be sent.
Quantity in Commerce 9
Distribution Distributed in DC and the states of MA, and OK.
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 = HXX and Original Applicant = SPINEFRONTIER, INC.
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