Date Initiated by Firm |
October 21, 2015 |
Create Date |
November 20, 2015 |
Recall Status1 |
Terminated 3 on June 24, 2016 |
Recall Number |
Z-0321-2016 |
Recall Event ID |
72541 |
510(K)Number |
K020069
|
Product Classification |
Motor, drill, pneumatic - Product Code HBB
|
Product |
Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes. |
Code Information |
Catalog Number: 16TA24, Lot Number: 0006936810 |
Recalling Firm/ Manufacturer |
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution 4620 N Beach St Haltom City TX 76137-3219
|
For Additional Information Contact |
David Leers 817-788-6587
|
Manufacturer Reason for Recall |
The wire pass hole is not present on the tools.
|
FDA Determined Cause 2 |
Process control |
Action |
A recall letter was mailed to consignees on October 21, 2015. |
Quantity in Commerce |
9 pieces |
Distribution |
Distributed in the states of California, New York, and Texas and the country of Belgium. |
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.
|
510(K) Database |
510(K)s with Product Code = HBB and Original Applicant = MEDTRONIC MIDAS REX
|