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Class 2 Device Recall Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device |
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Date Initiated by Firm |
December 06, 2017 |
Create Date |
January 14, 2018 |
Recall Status1 |
Terminated 3 on November 04, 2019 |
Recall Number |
Z-0352-2018 |
Recall Event ID |
78790 |
Product Classification |
Injector, vertebroplasty (does not contain cement) - Product Code OAR
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Product |
Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R |
Code Information |
UDI 00643169097254 Lot Numbers: WI424428, WI428822, WI435227, WI439940, WI442555, WI446722, WI449819, WI455595, WI459477, WI463434, WI472175, WI472178, WI472176, WI472177, WI474575 |
Recalling Firm/ Manufacturer |
Medtronic Sofamor Danek USA Inc 1800 Pyramid Pl Memphis TN 38132-1703
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For Additional Information Contact |
Eric Epperson 901-344-1435
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Manufacturer Reason for Recall |
Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument.
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FDA Determined Cause 2 |
Process control |
Action |
Medtronic distributed a voluntary removal notice via FedEx courier service to impacted U.S. consignees on 06 DEC 2017. The recall notice stated the following:
"If he/she has not already done so, your Sales Representative will contact you to facilitate the return of any impacted products you may have in your possession. Please disseminate this information to additional personnel
within your facility as appropriate, and maintain a copy of this notice in your records.
Instructions to Customers:
1.) Please locate and remove the impacted product from normal storage locations. Do not use this product.
2.) Complete the enclosed Customer Confirmation Form and return
3.) As applicable, contact your Medtronic Sales Representative to coordinate the return and replacement of affected product." |
Quantity in Commerce |
3,319 units |
Distribution |
US. Austria, Belgium, Bulgaria, Canada, France, Germany, Italy, Lebanon, Luxembourg, Portugal, South Africa, US |
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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