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 |
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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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510(K) Database | 510(K)s with Product Code = HXX
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