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U.S. Department of Health and Human Services

Class 2 Device Recall Rocker Reducer

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 Class 2 Recall
Rocker Reducer
see related information
Date Posted February 08, 2007
Recall Status1 Terminated on July 16, 2007
Recall Number Z-0411-2007
Recall Event ID 37066
Premarket Notification
510(K) Number
K042210 
Product Classification Orthosis, Spinal Pedicle Fixation - Product Code MNI
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, Tennessee 38133-3957
For Additional Information Contact Bert Kelly
901-396-3133
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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MNI and Original Applicant = MEDTRONIC SOFAMOR DANEK
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