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U.S. Department of Health and Human Services

Class 2 Device Recall Atlas Spine Torque Limiting Handle

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  Class 2 Device Recall Atlas Spine Torque Limiting Handle see related information
Date Initiated by Firm July 26, 2013
Create Date May 06, 2016
Recall Status1 Terminated 3 on July 26, 2019
Recall Number Z-1616-2016
Recall Event ID 73657
510(K)Number K063205  K091406  
Product Classification Spinal vertebral body replacement device - Product Code MQP
Product Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000
Used to rotate implant into position
Code Information Lots #: 8887, 000073, 000135, 00434, and 02518.
Recalling Firm/
Manufacturer		 Atlas Spine, Inc.
1555 Jupiter Park Dr Ste 4
Jupiter FL 33458-8085
For Additional Information Contact Thomas G. Smith
561-354-1108 Ext. 102
Manufacturer Reason
for Recall		 The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.
FDA Determined
Cause 2		 Device Design
Action Atlas Spine, Inc. informed all consignees of the recall and sub-recall on July 26, 2013, in person, electronically, and/or via email. Firm takes the responsibility of tracking of set return and inventory control of the product. For questions regarding this recall call 561-354-1108, ext 102.
Quantity in Commerce 16
Distribution Nationwide Distribution to FL, MO, and WV.
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 = MQP and Original Applicant = ATLAS SPINE LLC
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