| Class 2 Device Recall Prestige Cervical Disc System, Implant Trial | |
Date Initiated by Firm | September 04, 2007 |
Date Posted | December 19, 2007 |
Recall Status1 |
Terminated 3 on November 03, 2008 |
Recall Number | Z-0141-2008 |
Recall Event ID |
44953 |
PMA Number | P060018 |
Product Classification |
Cervical Disc System - Product Code MJO
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Product | Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972247, SIZE 7 X 14, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA |
Code Information |
Lot Numbers: CN06M012, CN07A025, 434167, 510185, 511648, 510180, 511650, 510189, 515311, 513692, 521191, 523113, 421195 and 521188 |
Recalling Firm/ Manufacturer |
Medtronic Sofamor Danek USA Inc 1800 Pyramid Place Memphis TN 38132-1719
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For Additional Information Contact | Bert Kelly 901-396-3133 |
Manufacturer Reason for Recall | Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated. |
FDA Determined Cause 2 | Device Design |
Action | The firm notified their consignees of the problem and the recall by Urgent Medical Device Recall letter, telephone calls and electronic mail on 09/04/2007. Instructions include requests to immediately quarantine the product and hold for recalling firm collection. |
Quantity in Commerce | 196 units |
Distribution | Nationwide |
Total Product Life Cycle | TPLC Device Report |
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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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PMA Database | PMAs with Product Code = MJO
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