Z-1016-2009

Medtronic TSRH Spinal System, 3Dx Splined Connector, Medium; Medtronic Sofamor Danek, Memphis, TN; REF...

Name: Z-1016-2009 Medtronic TSRH Spinal System, 3Dx Splined Connector, Medium; Medtronic Sofamor Danek, Memphis, TN; REF...
Creator: Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
Published: 2008-10-31
License: https://open.fda.gov/license/

Warsaw Orthopedic, Inc. / initiated 2008-10-31 / Terminated / root cause: manufacturing process

FDA source

Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK began a recall of Medtronic TSRH Spinal System, 3Dx Splined Connector, Medium; Medtronic Sofamor Danek, Memphis, TN; REF 8351511. The device is intended for orthosis, spinal... on 2008-10-31. The reason FDA records is "The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1016-2009
Status: Terminated
Initiated: 2008-10-31
Posted: 2009-03-12
Terminated: 2009-11-18
Recalling firm: Warsaw Orthopedic, Inc.
Product: Medtronic TSRH Spinal System, 3Dx Splined Connector, Medium; Medtronic Sofamor Danek, Memphis, TN; REF 8351511. 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.
Product code: MNI Orthosis, Spinal Pedicle Fixation
Reason for recall: The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation.
Root cause tag: manufacturing process
FDA root cause: 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: 446
Distribution: Nationwide Distribution including states of Arizona, Connecticut, Georgia, Indiana, Minnesota, New Jersey, New York, South Carolina, Texas and Washington.
Product codes and lots: All lots.

Product code MNI

K072317Class IIModification To:tsrh Spinal SystemMedtronic Sofamor Danek USA, Inc. / cleared 2007-09-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)