| Class 2 Device Recall ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Tapping Variable Screw Caddy | |
Date Initiated by Firm | July 06, 2011 |
Date Posted | August 10, 2011 |
Recall Status1 |
Terminated 3 on April 26, 2013 |
Recall Number | Z-2984-2011 |
Recall Event ID |
59221 |
Product Classification |
Orthopedic Surgical Instrument, Screw Caddy. - Product Code XLH
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Product | ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Tapping Variable Screw Caddy (176-513).
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
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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 | 873 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. |
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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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