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U.S. Department of Health and Human Services

Class 2 Device Recall ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Drilling Fixed Screw Caddy

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  Class 2 Device Recall ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Drilling Fixed Screw Caddy see related information
Date Initiated by Firm July 06, 2011
Date Posted August 10, 2011
Recall Status1 Terminated 3 on April 26, 2013
Recall Number Z-2985-2011
Recall Event ID 59221
Product Classification Orthopedic Surgical Instrument, Screw Caddy. - Product Code XLH
Product ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Drilling Fixed Screw Caddy (976-516).
Medtronic Sofamor Danek USA, Inc.

This instrument is a precision device which incorporates a measuring function.
Code Information **All lots.
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek USA Inc
1800 Pyramid Place
Memphis TN 38132
For Additional Information Contact Marybeth Thorsgaard
901-396-3133 Ext. 4124
Manufacturer Reason
for Recall		 Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws.
FDA Determined
Cause 2		 Process control
Action Medtronic Sofamor Danek USA, Inc. sent "Voluntary Recall - Medtronic" letters on July, 2011 to all affected customers. The letter included; description of product and problem, and asked customers to stop using the product. Customers are asked to contact their Sales Representatives for replacement. For question on this recall call Medtronics Global Quality Department at (800) 876-3133.
Quantity in Commerce 191 units
Distribution Worldwide Distribution: Nationwide distribution including the states of MN, OK, IL, AK, CA, PA, UT, LA, SC, NY, MI, GA, WI, KY, AL, MO, AZ, TN, TX, MA, NE, OH, FL, CO, MT, CT, VA, NC, NH, WA, WV, WY, IN, IA, KS, MT, ME, DE, DC, NJ, MD, MS, NV, HI, ID, ND, and AR; and the country of Uruguay.
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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