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U.S. Department of Health and Human Services

Class 2 Device Recall ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE

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 Class 2 Recall
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE
see related information
Date Posted October 10, 2012
Recall Status1 Terminated on August 15, 2013
Recall Number Z-0037-2013
Recall Event ID 63157
Premarket Notification
510(K) Numbers
K021461  K063100  K081038 
Product Classification Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
Product ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Code Information All lots except those starting with SY
Recalling Firm/
Manufacturer
Medtronic Sofamor Danek USA Inc
1800 Pyramid Place
Memphis, Tennessee 38132
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Rita Tate
901-396-3010
Manufacturer Reason
for Recall
Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Medtronic conducted a conference call on August 30, 2012 and sent an "URGENT VOLUNTARY RECALL" notice dated September 3, 2012 to all affected customers. The notice identified the product, problem, and actions to be taken by the customers. A Recall Questionnaire Form was attached to the letter for customers to complete and return. Contact your Medtronic Sales representative or the firm's Global Quality Department at 800-876-3133, ext. 3197 for questions regarding this notice.
Quantity in Commerce 1014 units
Distribution Worldwide Distribution-USA (nationwide) and the countries of India, Netherlands, Hong Kong, S. L Korea, Singapore, Canada, Australia, Japan, and Mexico.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KWQ and Original Applicant = MEDTRONIC SOFAMOR DANEK
510(K)s with Product Code = KWQ and Original Applicant = MEDTRONIC SOFAMOR DANEK, INC.
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