Medtronic TSRH Spinal System, 3Dx Splined Connector, Large; Medtronic Sofamor Danek, Memphis, TN; REF 8351512. The devic

FDA device recall Z-1017-2009 · posted 2009-03-12 · Terminated

Recall details

Recalling firm

Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK

Reason for recall

The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

MNI

Quantity affected

119

Distribution

Nationwide Distribution including states of Arizona, Connecticut, Georgia, Indiana, Minnesota, New Jersey, New York, South Carolina, Texas and Washington.

Date initiated

2008-10-31

Date posted

2009-03-12

Date terminated

2009-11-18

Location

Warsaw, IN

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