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U.S. Department of Health and Human Services

Class 2 Device Recall adjustable drill stop

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  Class 2 Device Recall adjustable drill stop see related information
Date Initiated by Firm March 13, 2012
Date Posted April 19, 2012
Recall Status1 Terminated 3 on April 30, 2013
Recall Number Z-1442-2012
Recall Event ID 61453
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product ATLANTIS(TM) Anterior Cervical Plate System Adjustable Drill Stop, REF 876-460, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132

Product Usage:
Manual orthopedic adjustable drill stop
Code Information Lot Numbers: 730, 15505, 27527, 28134, 29419, 29430, 31158, 33861, 34004, 35521, 38507, 38843, 41963, 43416, 43725, 49011, 49017, 50586, 50587, 53065, 53386, 53894, 55388, 56074, 62942, 64271, 65090, 65565, 79884, 83604, FA07M031, FA08A004, FA08E004, FA08H001, FA08H027, FA08J008, FA09J007, FA09J007L, FA10F036, FA10J007, FA10L012, FA11A024, FA11F004, FA11G011, FA11H055, IT03G024, IT03H012, IT03J010, IT03J039, IT03K048, IT04D024, IT05M002, IT06L043, IT07D014, IT07G041, IT07J024, IT07J088, IT10113, IT10336, IT10411, IT10412, IT10413, IT10966, IT10967, IT10968  
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek USA Inc
1800 Pyramid Place
Memphis TN 38132
For Additional Information Contact Marybeth Thorsgaard
901-396-1800
Manufacturer Reason
for Recall		 Drill stops may be bypassed when the device is used with powered drilling instruments.
FDA Determined
Cause 2		 Device Design
Action Medtronic notified their US Sales force on March 5, 2012, of the upcoming field action. The written "Voluntary Recall" communications were disseminated March 13 and March 14 to the US consignees. The letter identified the affected products, problem and actions to be taken. Customers are instructed to 1) disseminate this information to personnel within their facility as appropriate; 2) review work area, district sales office, and sample inventory for affected product; 3) complete the attached Risk Manager Questionnaire and return any recalled product; and 4) Sign and acknowledge the attached Sales Rep Questionnaire indicating receipt of this letter. For questions or concerns, contact your Medtronic Sales Representative or Global Quality Department at 800-876-3133, extension 3197.
Quantity in Commerce 2540 units
Distribution Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Barbados, Brazil, Netherlands, Hong Kong, Japan, Korea, Columbia, Chile, Canada, India, Jamaica, Switzerland, Costa Rica, Ecuador, and Mexico.
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.
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