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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic TSRH 3DX Splined Connector

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  Class 2 Device Recall Medtronic TSRH 3DX Splined Connector see related information
Date Initiated by Firm October 31, 2008
Date Posted March 12, 2009
Recall Status1 Terminated 3 on November 18, 2009
Recall Number Z-1017-2009
Recall Event ID 50185
510(K)Number K072317  
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code MNI
Product Medtronic TSRH Spinal System, 3Dx Splined Connector, Large; Medtronic Sofamor Danek, Memphis, TN; REF 8351512.

The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions.
Code Information All lots.
Recalling Firm/
Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
2500 Silveus Crossing
Warsaw IN 46582-8598
For Additional Information Contact
800-876-3133 Ext. 6333
Manufacturer Reason
for Recall
The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation.
FDA Determined
Cause 2
Process control
Action Hospital risk managers and implanting physicians were notified separately by letters dated 1/9/09. The letters advised of the recall, reported that a firm representative would visit the facility to pick up the recalled products. Physicians were instructed to closely monitor their patients during postoperative visits, to notify any other physician who may be monitoring the patient in lieu of the implanting physician, and to advise their patients to contact them immediately if they have any sudden and significant symptoms (increased discomfort, sudden change in their clinical symptoms, or new symptoms such as leg pain, back pain or irritation of local tissue). Customers were also instructed to complete and return the attached questionnaire to Medtronic SOFAMOR DANEK via mail (enclosed self-addressed stamped envelope) or fax at 901-399-2047. Direct questions to your Medtronic SOFAMOR DANEK Sales Representative or the firm's Global Quality Department at 800-876-3133, extension 6333.
Quantity in Commerce 119
Distribution Nationwide Distribution including states of Arizona, Connecticut, Georgia, Indiana, Minnesota, New Jersey, New York, South Carolina, Texas and Washington.
Total Product Life Cycle TPLC Device Report

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 = MNI and Original Applicant = MEDTRONIC SOFAMOR DANEK USA, INC.