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Class 2 Device Recall Rocker Reducer |
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Date Initiated by Firm |
December 18, 2006 |
Date Posted |
February 08, 2007 |
Recall Status1 |
Terminated 3 on July 16, 2007 |
Recall Number |
Z-0411-2007 |
Recall Event ID |
37066 |
510(K)Number |
K042210
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Product Classification |
spinal implant instrument - Product Code MNI
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Product |
Rocker Reducer, part of the SiLo Spinal System, REF 8880014, Rx only, Material: Stainless Steel, qty: 1 ea, non-sterile, Medtronic Sofamor Danek, 1800 Pyramid Place Memphis, TN 38132, USA, Manufactured at: Bartlett, Tennessee, USA |
Code Information |
Lot numbers: MH05F006 and MH05J015 |
Recalling Firm/ Manufacturer |
Medtronic Sofamor Danek Instrument Manufacturing 2975 Brother Blvd Bartlett TN 38133-3957
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For Additional Information Contact |
Bert Kelly 901-396-3133
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Manufacturer Reason for Recall |
Due to a manufacturing error, the proximal end may deform causing the protrusions that engage the associated implant to break off of the instrument during use.
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FDA Determined Cause 2 |
Other |
Action |
The firm sent out the recall letter via Federal Express to direct consignees on 12/18/2006. The letter explained the problem, requested discontinuation of use and stated that sales representatives would be coordinating the retrieval and replacement of the device. |
Quantity in Commerce |
58 units |
Distribution |
Worldwide, including USA, the Netherlands, Canada, Australia, and the Bahamas. |
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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510(K) Database |
510(K)s with Product Code = MNI and Original Applicant = MEDTRONIC SOFAMOR DANEK
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