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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 Device Recall Tipped Tapered Solid Driver (Screwdriver) see related information
Date Initiated by Firm May 09, 2012
Date Posted August 13, 2013
Recall Status1 Terminated 3 on January 10, 2014
Recall Number Z-1957-2013
Recall Event ID 64994
510(K)Number 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 MA 01915-6516
For Additional Information Contact
978-232-3990
Manufacturer Reason
for Recall		 The nipple of the tipped driver broke off when surgeons were attempting to insert the screw.
FDA Determined
Cause 2		 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 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 = HXX and Original Applicant = SPINEFRONTIER, INC.
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