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U.S. Department of Health and Human Services

Class 2 Device Recall Endoskeleton TC Interbody System with Titan nanoLOCK

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  Class 2 Device Recall Endoskeleton TC Interbody System with Titan nanoLOCK see related information
Date Initiated by Firm March 17, 2021
Create Date April 20, 2021
Recall Status1 Terminated 3 on May 03, 2023
Recall Number Z-1440-2021
Recall Event ID 87626
510(K)Number K183557  K192018  K141953  
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Product Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.
Code Information GTIN 00191375013167, Lot Number TM0126572
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek USA, Inc
4340 Swinnea Rd
Memphis TN 38118-6603
For Additional Information Contact Victor Rocha
901-399-2401
Manufacturer Reason
for Recall		 The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.
FDA Determined
Cause 2		 Packaging process control
Action The firm initiated the recall by letter on 03/19/2021, The letter requested that the consignee locate and isolate the impacted product and contact the Medtronic Sales Representative to coordinate the return and replacement of the device.
Quantity in Commerce 11 devices
Distribution US Nationwide distribution.
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 = MAX and Original Applicant = Titan Spine, Inc
510(K)s with Product Code = MAX and Original Applicant = TITAN SPINE, LLC
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